Product: 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.
Recall initiated: 20200414
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated