Drug product
Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05
D-1434-2012
Product summary
- Event
- Event 62591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1656 bottles
- Official record key
drug-enforcement:D-1434-2012
Official wording
Reason: Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
Code information: C201293 Exp Date 08/2013
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets
-
Labeling or packaging
mislabeled