Estradiol recalled over foreign material
- Recall date
- April 14, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- B & B Pharmaceuticals, Inc. recalls Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-99…
- Recall number
- D-1244-2020
- FDA classification
- Class II
- Brand / firm
- B & B Pharmaceuticals, Inc.
- Sold / distributed
- USA Nationwide
Why it was recalled
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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