Why it was recalled
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Product description
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
Lot numbers, UPCs & expiration codes
Lot #: 19140414, Exp 12/2020
Where it was sold
Nationwide in the USA
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-0827-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 22, 2020
- FDA report date
- Feb 12, 2020
- Quantity
- 4728 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-0827-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84750
- Address
- 339 Jefferson Rd Ste 101
- Code information
- Lot #: 19140414, Exp 12/2020
- Postal code
- 07054-3707
- Report date
- Feb 12, 2020
- Product type
- Drugs
- Recall number
- D-0827-2020
- Classification
- Class III
- Recalling firm
- Ascend Laboratories LLC
- Product quantity
- 4728 bottles
- Termination date
- Oct 27, 2021
- Reason for recall
- Failed Dissolution Specifications: low out of specification results for dissolution testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 22, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 5, 2020