Recalls / Class III
Class IIID-0118-2017
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.
- Affected lot / code info
- Lot #: 1136091A, Incorrectly Labeled Exp: 03/18
Why it was recalled
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Recalling firm
- Firm
- Actavis Laboratories, FL, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4955 Orange Dr, Davie, Florida 33314-3902
Distribution
- Quantity
- 15,984 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-08-30
- FDA classified
- 2016-11-01
- Posted by FDA
- 2016-11-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0118-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.