October 2019 FDA Recall Isotretinoin by Amneal Pharmaceuticals, Inc.
D-0321-2020 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Amneal Pharmaceuticals, Inc. on October 16, 2019 for the product Isotretinoin. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Recalled product was distributed to retailers and wholesalers who may have further distribute the product. and the recall is currently terminated.
Recall Number: D-0321-2020
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
10-16-2019
11-20-2019
2460 cartons/3 blister cards/10 capsules each
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amneal Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
11-09-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Batch# Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
