Recall: D-0321-2020

Class III - Minor Violations

Class IIIClassification

2019-10-16Initiated

TerminatedStatus

Amneal Pharmaceuticals, Inc.Firm

Product

Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3

Reason

Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.

Distribution

Recalled product was distributed to retailers and wholesalers who may have further distribute the product.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.