B & B Pharmaceuticals, Inc. recalls Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-990
Recalled April 22, 2020 · FDA recall D-1244-2020 · B & B Pharmaceuticals
Hazard
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level. · FDA Class II
Units
3,825 grams
Sold at
USA Nationwide
Description
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
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
Manufacturer(s)
B & B Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →