FDAFDA · Food and drugs·Recall number D-1244-2020
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
Published April 22, 2020 · Recall initiated: April 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B & B Pharmaceuticals, Inc.
- Distributor
- USA Nationwide
- Lot
- Lot #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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