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Del Taco, Hamilton Road, Columbus, GA, USA
Latest report: May 27, 2020 9:34 AM
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108
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level. This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of... See More this product are impacted.
Lot AC13786 is being recalled due to the presence of Ralstonia pickettii bacteria (“R. pickettii”), which was discovered by the manufacturer through routine testing. R. pickettii is present in the natural environment (soil, water) and for healthy individuals with intact skin, is unlikely to cause any localized or systemic infections. However, for individuals who are immunocompromised, or whose skin is not intact (i.e. sunburn, psoriasis, abrasions), there is a reasonable possibility that systemic infections may occur if the product is contaminated with R. pickettii due to the presence of the corticosteroid component which enhances absorption of the ointment. If this bacterium is circulating in the human blood stream it can cause life-threatening, invasive infections such sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues.
To date, Taro has not received any adverse event reports related to this lot.
The one (1) lot being recalled is as follows:
Lot # AC13786
Amount: 96 units
Expiration Date: December 2022
Clobetasol Propionate Ointment USP, 0.05% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses and is packaged in 60 g aluminum tubes with polypropylene puncture-tip caps. Each 60 g tube is labeled to indicate the name of the product, Clobetasol Propionate Ointment USP, 0.05% and the NDC # 51672-1259-3 (see image of container label below). The Lot Number and Expiration Date are displayed on the bottom of each tube and the end flap of the product carton.
Ninety-six (96) units of Lot AC13786 were distributed to two wholesale distributors in the U.S. market between November 16 and December 6, 2021. These two wholesale distributors may have further distributed this lot to their retail customers for prescription dispensing to patients who were prescribed Clobetasol Propionate Ointment USP, 0.05%, 60 g.
Retail customers that have any quantities of Lot AC13786 which is being recalled, should stop distribution and return any unsold units to their wholesaler. 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company name: Taro Pharmaceuticals USA, Inc.
Brand name: Taro
Product recalled: Clobetasol Propionate
Reason of the recall: Presence of Ralstonia pickettii bacteria
FDA Recall date: December 30, 2021
Check the full recall details on fda.gov
Source: FDA See Less
110
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ET
ethelt9
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I mailed a package from Lake Luzerne, NY on 12/8/21 and tracking states it arrived in Teterboro, NJ on 12/12/21. There are no further updates other than "in transit" and the package has not been delivered. On their website, it states this facility is permanently closed! Tracking... See More #9505 5124 5581 1342 2096 34 See Less
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Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal... See More on the proximal end of the device handle detaching during use.
RISK STATEMENT: The Destino Twist 14T Model DST1405525 & Guidestar 14F Model D141103 detachment of the hub cap and seal could lead to bleeding at the proximal end of the device and/or air embolism for the patient during intracardiac, renal or other peripheral placements procedures.
Oscor Inc. has reported two (2) Medical Device Reports to the FDA related to detachment of hub cap and seal on the proximal end of the device handle. The recall is limited to the two model numbers and lot numbers outlined above. There are no other recalls associated with this product.
PRODUCT INFORMATION: The product is steerable guiding sheath intended for the introduction of diagnostic and therapeutic devices into the human vascular, including but not limited to intracardiac, renal or other peripheral placements; it cannot be use for neural placements. The product is provided sterile, one unit per pouch / tray for details and can be identified on the printed labeling with the information below (1, 2, and 3).
The affected Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 were distributed Worldwide to distributors and hospitals from June 8, 2021 to November 30, 2021.
Recalled Product Impacted (1)
- Destino Twist 14F (DST1405525). UDI Number: 885672011123. Lot Number: PQOC13475. Expiration Date 10-01-2021. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14073. Expiration Date 11-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14072. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14071. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13834. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13828. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13827. Expiration Date 08-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12995. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12632. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12633. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12345. Expiration Date 06-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12330. Expiration Date 06-01-2025. Packaging State Type: Sterile.
Destino 14F Twist Model (2)
Product: Destino Twist 14F
GTIN (Unit): 00885672011123
Model: DST1405525
Sheath & Dilator: S55CM D73CM
French Size: 14F
Quantity: 6 Units
Guidestar 14F - Model (3)
Product: Guidestar 14F
GTIN (Unit): 00885672010911
Model: D141103
Sheath & Dilator: S71CM D89CM
French Size: 14F
Quantity: 543 Units
Company name: Oscor Inc.
Brand name: Oscor
Recalled: Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 steerable guiding sheath
Reason of the recall: Hub cap and seal on the proximal end of the device handle may detach during use
FDA Recall date: January 12, 2022
Check the full recall details on fda.gov
Source: FDA See Less
109
Package ID: 0652097001
Delivery conf at Teterboro: 92748909840515553021375525
Ordered small package that has been sitting at Teterboro since 12/8/21…it’s been a month and still not delivered. This is ridiculous!!!!! See Less
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Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination. Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing... See More life-threatening inflammation of the heart, could result in infections that could be life-threatening.
To date, Lohxa LLC has not received any reports of adverse events related to this recall.
The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 mL unit-dose cups. The product is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-731-24. The affected Senna Syrup 8.8mg/5mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label attached.
Product was distributed to AvKare (Wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers. Outer carton labeling (see images) Unit-Dose Cups (see image) Lohxa LLC is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to place of purchase.
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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company name: Lohxa LLC
Brand name: AVpak
Product recalled: Senna Syrup 5mL
Reason of the recall: Potential microbial contamination
FDA Recall date: January 12, 2022
Check the full recall details on fda.gov
Source: FDA See Less
110
Padagis US LLC announced today it has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the table below. Out of an abundance of caution, this product is being recalled from the market due to a complaint received... See More that a unit may not dispense.
There is a risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit. This recall applies only to the 12g spray bottle and not the 4.9g spray bottle of this medication.
- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 150892
- Expiration: Oct 2022
- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 153199
- Expiration: Feb 2023
- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 156041
- Expiration: Apr 2023
Company name: Padagis
Brand name: Perrigo
Product recalled: Nitroglycerin Lingual Spray
Reason of the recall: Unit may not properly dispense medication.
FDA Recall date: December 27, 2021
If the product does not deliver the appropriate amount of nitroglycerin, the patient will likely continue to experience chest pain. The label advises that if relief is not obtained after 3 doses over 15 minutes the patient should promptly seek medical attention. To date, Padagis has not received any reports of adverse events related to this recall.
Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of chest pain due to coronary artery disease in adult patients. All packaging and branding on affected units is that of Perrigo Company PLC. The product is packaged in a 12 g bottle contained within a carton. The medication was distributed Nationwide in the USA to wholesalers and retailers.
Healthcare providers, distributors, and retailers that have product which is being recalled should stop distribution. Patients who have this product should contact their healthcare provider for an alternate replacement before returning the recalled product.
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 See Less
109
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