Why it was recalled
Crystallization; Complaints that cream appears to have crystallized
Product description
Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
Lot numbers, UPCs & expiration codes
a) Lot (Exp): 8020 (02/17), 8096 (07/18), 8125 (08/18), 8169 (10/18). NDC 58980-680-50 b) Lot (Exp): 8020 (02/17), 8125 (08/18), 8170 (10/18). NDC 58980-680-90
Where it was sold
Nationwide and PR
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-1464-2016
- Classification
- Class III
- Status
- Completed
- Recall initiated
- May 26, 2016
- FDA report date
- Aug 31, 2016
- Quantity
- a) 12,345 tubes; b) 8,578 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Stratus Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1464-2016, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Completed
- Country
- United States
- Event ID
- 74519
- Address
- 12379 SW 130th St
- Code information
- a) Lot (Exp): 8020 (02/17), 8096 (07/18), 8125 (08/18), 8169 (10/18). NDC 58980-680-50 b) Lot (Exp): 8020 (02/17), 8125 (08/18), 8170 (10/18). NDC 58980-680-90
- Postal code
- 33186-6208
- Report date
- Aug 31, 2016
- Product type
- Drugs
- Recall number
- D-1464-2016
- Classification
- Class III
- Recalling firm
- Stratus Pharmaceuticals Inc
- Product quantity
- a) 12,345 tubes; b) 8,578 tubes
- Reason for recall
- Crystallization; Complaints that cream appears to have crystallized
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
- Distribution pattern
- Nationwide and PR
- Recall initiation date
- May 26, 2016
- Initial firm notification
- Letter
- Center classification date
- Aug 23, 2016