Drug product
Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.
D-0118-2017
Product summary
- Event
- Event 75042
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 15,984 bottles
- Official record key
drug-enforcement:D-0118-2017
Official wording
Reason: Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Code information: Lot #: 1136091A, Incorrectly Labeled Exp: 03/18
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing