Why it was recalled
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Product description
Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.
Lot numbers, UPCs & expiration codes
Lot: 93802, EXP NOV 2019
Where it was sold
Nationwide in the US
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-0929-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 1, 2017
- FDA report date
- Jul 5, 2017
- Quantity
- 648 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allergan Sales, LLC
Original FDA data
Every field from FDA enforcement report D-0929-2017, exactly as published.
Show all FDA fields
- City
- Waco
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77143
- Address
- 8301 Mars Dr
- Code information
- Lot: 93802, EXP NOV 2019
- Postal code
- 76712-6578
- Report date
- Jul 5, 2017
- Product type
- Drugs
- Recall number
- D-0929-2017
- Classification
- Class II
- Recalling firm
- Allergan Sales, LLC
- Product quantity
- 648 units
- Termination date
- May 1, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- May 1, 2017
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2017