Biocon Pharma Inc. recalled 28,157 bottles of PRAZOSIN HYDROCHLORIDE capsules, distributed nationwide in the USA. The recall cites cGMP deviation due to detection of N-nitroso-prazosin impurity C above acceptable limits. Stop using the product immediately and contact Appco Pharma LLC or your healthcare provider for guidance.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Consumers and healthcare providers should stop using this product immediately. Contact Appco Pharma LLC or your healthcare provider for guidance. Notification method: E-Mail
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Prazosin Hydrochloride capsules are prescription medications used to treat high blood pressure and other conditions. They are sold in patient pharmacies and distributed through healthcare channels.
The product contains a nitrosamine impurity, N-nitroso-prazosin impurity C, detected above acceptable limits. Nitrosamines are potential carcinogens in long-term exposure.
This recall is not described as part of a broader industry pattern.
Consumers may be exposed to a nitrosamine impurity. The recall affects a large number of bottles nationwide and requires immediate cessation of use.
Label on the bottle and the FDA enforcement recall page linked in the notice.
No timeline provided for refunds or replacements in the notice.
Keep the bottle, labels, recall notice, and any correspondence with the manufacturer. Document purchase date and lot numbers.
NDC: 70377-068-11 Bottle count: 100 capsules per bottle Manufactured for: Biocon Pharma Inc., Iselin, NJ Manufactured by: Appco Pharma LLC, Piscataway, NJ Quantity recalled: 28,157 bottles Distribution: USA nationwide Lot numbers: 2406255UC, 2406256UC, 2407313UC, 2408351UC, 2408352UC, 2509311UC Expirations on recalled lots: 2026 May to 2027 Sep (per listed lots)
No injuries or incidents have been reported.
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