Reported Apr 22, 2020 · Terminated
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC…
B & B Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B & B Pharmaceuticals, Inc. · 8591 Prairie Trail Dr Ste C600 · Englewood, CO · 80112-7075
Is this the product you have?
- 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 PharmaceuticalsInc. 800-499-3100
- Lot codes and dates
Lot #: 18K26-BB02-PR00553Reassay 10/09/2023 Product # 700365700362 & 700363
- Amount recalled
- 3,825 grams
Where it was sold
- Nationwide
Why it was recalled
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
This product could cause temporary or reversible health problems — stop using it.
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