Class II · Moderate risk Ongoing
Clindamycin Palmitate Hydrochloride for Oral Solution
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
amneal Metformin Hydrochloride Extended-Release Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What was recalled
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- NDC code
- 53746-0178-90
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1393-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Chloride recalls
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Class II · Moderate risk Ongoing
Dicyclomine Hydrochloride Capsules
Reason shortfill; reports of empty capsules.
Class II · Moderate risk Ongoing
Naropin
Reason Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Cool Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Optic Glow
Reason Lack of Assurance of Sterility
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