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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 1136091A, Incorrectly Labeled Exp: 03/18
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0118-2017
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Aug 30, 2016
- FDA report date
- Nov 9, 2016
- Quantity
- 15,984 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Laboratories, FL, Inc.
Original FDA data
Every field from FDA enforcement report D-0118-2017, exactly as published.
Show all FDA fields
- City
- Davie
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 75042
- Address
- 4955 Orange Dr
- Code information
- Lot #: 1136091A, Incorrectly Labeled Exp: 03/18
- Postal code
- 33314-3902
- Report date
- Nov 9, 2016
- Product type
- Drugs
- Recall number
- D-0118-2017
- Classification
- Class III
- Recalling firm
- Actavis Laboratories, FL, Inc.
- Product quantity
- 15,984 bottles
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 30, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2016