Reported Nov 20, 2019 · Terminated
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-.…
Amneal Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amneal Pharmaceuticals, Inc. · 50 Horseblock Rd · Brookhaven, NY · 11719-9509
Is this the product you have?
- Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-
- Distributed byAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
- Lot codes and dates
- Batch Numbers
BL10917BL11017BL11117Exp. date 11/2019
- Batch Numbers
- Amount recalled
- 2460 cartons/3 blister cards/10 capsules each
Why it was recalled
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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