Ascend minocycline ER tablets recalled for failed dissolution
Ascend Laboratories is recalling Minocycline Hydrochloride Extended-Release Tablets, 115 mg (lot 25141635, expires 4/30/2028) because testing found the tablets did not dissolve properly as required. This affects 360 bottles distributed nationwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Ascend Laboratories recalls
What to do
- Check if you have lot 25141635 (expiring 4/30/2028) of Ascend Minocycline 115 mg tablets.
- Contact your pharmacist or doctor about whether to continue taking this medication.
- Do not flush or throw away the medication; ask your pharmacist how to safely dispose of it.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 360 30-count bottles
- Illnesses reported
- None reported
- Manufactured in
- 135 Us Highway 202 206 Ste 15, N/A, Bedminster, NJ, United States
- Classification
- Class II
- Recall number
- D-0597-2026
In the FDA's words
- Description
- Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30 Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis Lot# 25141635, Exp 4/30/2028 Distribution: Nationwide in the USA Affected quantity: 360 30-count bottles
- Hazard
- Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
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