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.
Reported: February 12, 2020 Initiated: January 22, 2020 #D-0827-2020
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.
Reason for Recall
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Details
- Recalling Firm
- Ascend Laboratories LLC
- Units Affected
- 4728 bottles
- Distribution
- Nationwide in the USA
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ascend Laboratories LLC. Units affected: 4728 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 12, 2020. Severity: Low. Recall number: D-0827-2020.
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