Why it was recalled
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Product description
Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Made in India -- NDC 49884-902-52 (packets of 50 g) and NDC 49884-902-78 (cartons of five 50 g packets)
Lot numbers, UPCs & expiration codes
Lots M13012 (exp. date MAR 2015), M13014 (exp. date MAR 2015), M14036 (exp. date FEB 2016), and M14077 (exp. date JUL 2016)
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-0393-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 12, 2015
- FDA report date
- Mar 4, 2015
- Quantity
- 2856 cartons (each containing 5 packets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Pharmaceutical Inc.
Original FDA data
Every field from FDA enforcement report D-0393-2015, exactly as published.
Show all FDA fields
- City
- Spring Valley
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 70439
- Address
- 1 RAM Ridge Rd
- Code information
- Lots M13012 (exp. date MAR 2015), M13014 (exp. date MAR 2015), M14036 (exp. date FEB 2016), and M14077 (exp. date JUL 2016)
- Postal code
- 10977-6714
- Report date
- Mar 4, 2015
- Product type
- Drugs
- Recall number
- D-0393-2015
- Classification
- Class II
- Recalling firm
- Par Pharmaceutical Inc.
- Product quantity
- 2856 cartons (each containing 5 packets)
- Termination date
- May 2, 2017
- Reason for recall
- Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Made in India -- NDC 49884-902-52 (packets of 50 g) and NDC 49884-902-78 (cartons of five 50 g packets)
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 12, 2015
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2015