Why it was recalled
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Product description
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
Lot numbers, UPCs & expiration codes
Lot# E112, Exp 05/14 Lot# J062, Exp 09/14
Where it was sold
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-602-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 23, 2013
- FDA report date
- Jun 26, 2013
- Quantity
- 8,437 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mission Pharmacal Co
Original FDA data
Every field from FDA enforcement report D-602-2013, exactly as published.
Show all FDA fields
- City
- Boerne
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 64149
- Address
- 38505 Interstate 10 W
- Code information
- Lot# E112, Exp 05/14 Lot# J062, Exp 09/14
- Postal code
- 78006-8914
- Report date
- Jun 26, 2013
- Product type
- Drugs
- Recall number
- D-602-2013
- Classification
- Class III
- Recalling firm
- Mission Pharmacal Co
- Product quantity
- 8,437 bottles
- Termination date
- Mar 18, 2014
- Reason for recall
- Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 23, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2013