FDAFDA · Food and drugs·Recall number D-0827-2020
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.
Published February 12, 2020 · Recall initiated: January 22, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: low out of specification results for dissolution testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MINOCYCLINE HYDROCHLORIDE
- Manufacturer
- Ascend Laboratories LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 19140414, Exp 12/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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