Home / Recalls / B & B Pharmaceuticals, Inc. / D-1244-2020

D-1244-2020 Class II Terminated

Recalled by B & B Pharmaceuticals, Inc. — Englewood, CO

Recall Details

Product Type: Drugs
Report Date: April 22, 2020
Initiation Date: April 14, 2020
Termination Date: July 24, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,825 grams

Product Description

Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100

Reason for Recall

cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.

Distribution Pattern

USA Nationwide

Code Information

Lot #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363