FDA recall D-0321-2020

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-10-16

Report date

2019-11-20

Termination date

2020-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0321-2020