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

FDA recall notice · announced November 20, 2019 · Amneal Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

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

Notes

Distribution: Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
Lot/code information: Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
Quantity: 2460 cartons/3 blister cards/10 capsules each
Status: Terminated
Products in this recall event:
- 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 (D-0321-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.