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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- B & B Pharmaceuticals, Inc.
- Reason for Recall:
- cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Lot #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1244-2020