Verti products, Tampa FL. 33626
3 weeks ago •reported by user-dtwk5977
Yes. 1 ounce of some dietary supplement
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Perrigo Nitroglycerin Lingual Spray - recalled due to improper dispense medication, USA
2 years ago •source www.fda.gov
Recall notice
United States
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 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 www.fda.gov
Source: FDA
303
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Dr. Reddy’s Sapropterin Dihydrochloride Powder for Oral Solution - recalled due to decreased potency, USA
6 days ago •source www.fda.gov
Recall notice
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to
powder discoloration in some packets leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints. Sapropterin Dihydrochloride Powder for Oral Solution 100 mg was distributed nationwide to wholesalers/retailers. Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall to date.
Reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients. Chronically elevated Phe levels in infants and children are likely to cause permanent neurocognitive deficits, including permanent and irreversible intellectual disability, developmental delay, and seizures. Furthermore, elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart disease.
The product is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU) and is packaged in individual packets, 30 per carton. The affected Sapropterin Dihydrochloride Powder for Oral Solution 100mg lots include the following:
- Product Name: Javygtor™ (Sapropterin) Dihydrochloride) Powder for Oral Solution 100 mg, Lot Number: T2202812; T2204053; T2300975; T2300976; T2304356, Expiration date: 07/2025; 10/2025; 02/2026; 02/2026; 08/2026, NDC Number: 43598-097-30; 43598-097-30; 43598-097-30; 43598-097-30; 43598-097-30
- Product Name: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg, Lot Number: T2200352, Expiration date: 12/2024, NDC Number: 43598-477-30
Dr. Reddy’s Laboratories Inc. is notifying its distributors and customers by recall notification letters and is arranging for returns of all recalled products. Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should contact their physician before stopping use of the product. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should return it to their place of purchase.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Dr. Reddy’s Laboratories Inc
Brand name: Dr. Reddy’s
Product recalled: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg
Reason of the recall: Decreased Potency
FDA Recall date: April 23, 2024
Source: www.fda.gov
Reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients. Chronically elevated Phe levels in infants and children are likely to cause permanent neurocognitive deficits, including permanent and irreversible intellectual disability, developmental delay, and seizures. Furthermore, elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart disease.
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- Product Name: Javygtor™ (Sapropterin) Dihydrochloride) Powder for Oral Solution 100 mg, Lot Number: T2202812; T2204053; T2300975; T2300976; T2304356, Expiration date: 07/2025; 10/2025; 02/2026; 02/2026; 08/2026, NDC Number: 43598-097-30; 43598-097-30; 43598-097-30; 43598-097-30; 43598-097-30
- Product Name: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg, Lot Number: T2200352, Expiration date: 12/2024, NDC Number: 43598-477-30
Dr. Reddy’s Laboratories Inc. is notifying its distributors and customers by recall notification letters and is arranging for returns of all recalled products. Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should contact their physician before stopping use of the product. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should return it to their place of purchase.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Dr. Reddy’s Laboratories Inc
Brand name: Dr. Reddy’s
Product recalled: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg
Reason of the recall: Decreased Potency
FDA Recall date: April 23, 2024
Source: www.fda.gov
303
I received in the mail a container of Buoribose from subgenix, Sumter, SC, USA
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It was delivered to my address with someone else’s name on the package. I do not know what this product is or what the company is. It came from a fulfillment house in Tampa
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2800 n. Franklin rd
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Ref.# BB30209047968-209****
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