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
Recall Number: D-1244-2020
Firm: B & B Pharmaceuticals, Inc.
Classification: Class II
Status: Terminated
Report Date: 20200422
Initiation Date: 20200414
Termination Date: 20200724
Reason for Recall
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
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