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Sagent Phenylephrine Hydrochloride Injection - recalled due to lack of sterility, USA

March 11, 2021 11:00 PM

United States

Company name: Sagent Pharmaceuticals, Inc.
Brand name: Sagent
Product recalled: Phenylephrine Hydrochloride Injection
Reason of the recall: Lack of sterility assurance
FDA Recall date: March 11, 2021
Recall details: Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL). This product was manufactured by Indoco Remedies Ltd. and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Phenylephrine Hydrochloride Injection, USP to the user level as the result of a customer complaint due to potentially loose crimped vial overseas.

A non-integral crimped vial overseal may result in a non-sterile product. Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life-threatening. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated.

To date, Sagent has not received reports of any adverse events associated with this issue. Phenylephrine Hydrochloride Injection, USP is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important low blood pressure resulting primarily from the dilation of blood vessels, which decreases blood pressure in the setting of anesthesia. The product is supplied in 3 mL glass tubular vials. The lot numbers being recalled were distributed to hospitals, wholesalers and distributors nationwide in the USA from 11/17/2020 – 03/08/2021.

Phenylephrine Hydrochloride Injection, USP. Lot Number: PHT8IB2 | PHT9IB2 | PHT1JB2. Expiration Date: 08/2022 | 08/2022 | 09/2022. NDC Number: 25021-315-01. Distribution Dates: November 17, 2020 – March 8, 2021

Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots listed above. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall.

Consumers/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.

Customers or consumers with any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F, 8am-7pm CST.

Check the full recall details on fda.gov

Source: FDA

Reported By SafelyHQ.com User
More incidents from:
Drugs
Recall
United States

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April 6, 2021 5:00 PM

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Reason of the recall: Undeclared Tadalafil
FDA Recall date: April 06, 2021
Recall details: Company Announcement Cli... See Moreffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, PDE- 5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Yolo Studio has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.

The affected lot numbers of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Yolo Studio is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yolo Studio by phone at (201) 233-3521 Monday through Friday from 9am to 5pm eastern time zone or e-mail yolostudiodamazon@gmail.com.

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- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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“Company name: Yolo Studio
Brand name: PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500
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FDA Recall date: April 06, 2021
Recall details: Cliffside Park, NJ, Yol... See Moreo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction.

The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall. Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening.

Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Yolo Studio has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.

The affected lot numbers of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients.

It also encouraged online marketplaces to ensure these products are not sold on their platforms. Yolo Studio is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yolo Studio by phone at (201) 233-3521 Monday through Friday from 9am to 5pm eastern time zone or e-mail yolostudiodamazon@gmail.com.

Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

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Consumers with underlying medical issues who take Premium OrgaZen 7000 capsules and Ginseng Power 5000 with undeclared sildenafil and/or tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, NS NY Distributor Inc has not received any reports of adverse events related to this recall.

These tainted products are marketed as a dietary supplements for male sexual enhancement and are packaged in a single capsule blister foil sheet and sold in lots of 3 capsules, 5 capsules and 10 capsules. The affected lot numbers of Premium OrgaZen 7000, UPC 0 40232 18144 3, and Ginseng Power 5000, UPC 0 40232 18144 3 include all lots. Premium OrgaZen 7000 and Ginseng Power 5000 were distributed nationwide in the USA via the internet by seller account Beauty.Kor. and fulfilled by amazon at www.amazon.com.

NS NY Distributor Inc is notifying customers who purchased through Amazon seller account Beauty.Kor by this press announcement. Consumers that have Premium OrgaZen 7000 and Ginseng Power 5000 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact NS NY Distributors Inc by email at NSNYdistributors@gmail.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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“Company name: J. M. Smucker Co.
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The impacted products were sold at select Walmart stores in IL, MO, NE, NM, OK, UT, WI, and WY. No other Meow Mix® products are impacted by this recall. If pet parents have products matching the following description in their possession, they should stop feeding it to their cats and dispose of it immediately. This information can be found on the bottom and back of each bag.

- Meow Mix® Original Choice Dry Cat Food (30 LB Bag). Retail UPC Code: 2927452099. Lot Code: 1081804. Best If Used By Date: 9/14/2022
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Check the full recall details on fda.gov

Source: FDA
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“Company name: Becton, Dickinson and Company
Brand name: ChloraPrep
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FDA Recall date: April 20, 2021
Recall details: BD (Becton, Dickinson and Company), a leading global medical technology co... See Morempany, is voluntarily recalling specified lots of the ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) to the user level due to a defective applicator. The product is used as an antiseptic for the preparation of the patient's skin prior to surgery to help reduce bacteria that potentially can cause skin infection.

The ChloraPrep™ 26 mL Applicator contains glass ampules that house the sterile ChloraPrep™ solution. In normal circumstances, the product is activated by squeezing the wing on the applicator to break the ampule, which releases the solution to the sponge head for application to the patient’s skin. In certain lots, the applicator end cap was improperly secured due to a manufacturing error.

This can result in broken glass and solution dropping out of the applicator once activated. In some cases, the glass ampules can drop out before activation and shatter if striking a hard surface, resulting in solution and glass fragments scattering in the procedure area and potentially causing injury to patients and health care professionals.
These products were distributed in the United States and Puerto Rico.

BD Risk Assessment: Immediate health consequences could be lacerations to patient and/or user of the device.  It is possible that these could range from superficial to deep lacerations.  While BD has no current reports of severe injury, it is possible that lacerations could cause damage to structures such as nerves or tendons, however, this is considered unlikely.

Long-term health consequences could include superficial or deep lacerations that could lead to infection and scarring. “Flying” glass shards could potentially cause injury to the patient or user, including eye injuries. Splashing ChloraPrep™ solution could contact the eyes of the user or patient. If tissues or organs other than the skin and subcutaneous tissues are damaged, permanent impairment could occur. While blood loss could accompany these injuries, it would be readily controllable with simple standard measures.

To date, BD has received 56 complaints with only one laceration injury reported with respect to this issue. As part of the voluntary recall to the user level, the company is notifying customers and distributors affected by the recall. BD’s Customer Recall Notification provides instructions to customers and distributors for disposal and replacement of the impacted ChloraPrep™ 26 mL Applicator (see list of affected lot numbers in the link below).

Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product should be addressed to BD Customer Support at 1-844-8BD- LIFE (1-844-823-5433); When calling Monday- Friday between the hours of 9 a.m. to 6 p.m. ET, say “Recall” when prompted. For additional information, customers can visit www.bd-chloraprep-action.comExternal Link Disclaimer. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

The U.S. Food and Drug Administration (FDA) has been notified of this recall.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

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