Drug product
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
D-0542-2025
Product summary
- Event
- Event 97182
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7668 bottles
- Official record key
drug-enforcement:D-0542-2025
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Code information: Lot GB01616, expiration 2/28/2027
Distribution pattern: Nationwide in the US
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing