D-0118-2017 Class III Ongoing
FDA drug recall D-0118-2017 was initiated by Actavis Laboratories, FL, Inc. on August 30, 2016 and is designated Class III. Reason for recall: Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17. The recall status is ongoing. Affected quantity: 15,984 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 9, 2016
- Initiation Date
- August 30, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,984 bottles
Product Description
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.
Reason for Recall
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 1136091A, Incorrectly Labeled Exp: 03/18