Recalls / Class III
Class IIID-0827-2020
Product
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.
- Brand name
- Minocycline Hydrochloride
- Generic name
- Minocycline Hydrochloride
- Active ingredient
- Minocycline Hydrochloride
- Route
- Oral
- NDCs
- 67877-436, 67877-578, 67877-576, 67877-577, 67877-643, 67877-644, 67877-437, 67877-438
- FDA application
- ANDA204453
- Affected lot / code info
- Lot #: 19140414, Exp 12/2020
Why it was recalled
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Recalling firm
- Firm
- Ascend Laboratories LLC
- Manufacturer
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 4728 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2020-01-22
- FDA classified
- 2020-02-05
- Posted by FDA
- 2020-02-12
- Terminated
- 2021-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0827-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.