Why it was recalled
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Product 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
Lot numbers, UPCs & expiration codes
Lot #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1244-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 14, 2020
- FDA report date
- Apr 22, 2020
- Quantity
- 3,825 grams
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B & B Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1244-2020, exactly as published.
Show all FDA fields
- City
- Englewood
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 85440
- Address
- 8591 Prairie Trail Dr Ste C600
- Code information
- Lot #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363
- Postal code
- 80112-7075
- Report date
- Apr 22, 2020
- Product type
- Drugs
- Recall number
- D-1244-2020
- Classification
- Class II
- Recalling firm
- B & B Pharmaceuticals, Inc.
- Product quantity
- 3,825 grams
- Termination date
- Jul 24, 2020
- Reason for recall
- cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Apr 14, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 16, 2020