Why it was recalled
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Product description
Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435.
Lot numbers, UPCs & expiration codes
Lot #: 2FH0257, Exp 09/30/2017; 2GA0254, Exp 03/24/2018
Where it was sold
Nationwide in the USA
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-0881-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 13, 2017
- FDA report date
- Jun 14, 2017
- Quantity
- 48 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Spectrum Laboratory Products, Inc.
Original FDA data
Every field from FDA enforcement report D-0881-2017, exactly as published.
Show all FDA fields
- City
- New Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77398
- Address
- 755 and 769 Jersey Ave
- Code information
- Lot #: 2FH0257, Exp 09/30/2017; 2GA0254, Exp 03/24/2018
- Postal code
- 08901-3605
- Report date
- Jun 14, 2017
- Product type
- Drugs
- Recall number
- D-0881-2017
- Classification
- Class II
- Recalling firm
- Spectrum Laboratory Products, Inc.
- Product quantity
- 48 containers
- Termination date
- Feb 21, 2019
- Reason for recall
- CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 13, 2017
- Initial firm notification
- Letter
- Center classification date
- Jun 2, 2017