FDA-Drug2020-04-22Class II
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
B & B Pharmaceuticals, Inc.
Hazard
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Sold states
USA Nationwide
Affected count
3,825 grams
Manufactured in
8591 Prairie Trail Dr Ste C600, Englewood, CO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1244-2020Don't want to check this manually?
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