Why it was recalled
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Product description
Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320
Lot numbers, UPCs & expiration codes
20154 EXP.12/13, 20153 EXP.12/13, 20152 EXP.12/12, 20151 EXP.12/11, 20093 EXP.12/13, 20092 EXP.12/13, 20091 EXP.12/13, 20085 EXP.12/13, 20084 EXP.12/13, 20083 EXP. 2/13, 20082 EXP.12/13, 20073 EXP. 12/13, 20074 EXP. 12/13, 20075 EXP. 12/13, 20081 EXP.12/13, 20021 EXP. 12/13
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-1076-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 22, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 332508
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1076-2014, exactly as published.
Show all FDA fields
- City
- New London
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 66962
- Address
- 170 Broad St
- Code information
- 20154 EXP.12/13, 20153 EXP.12/13, 20152 EXP.12/12, 20151 EXP.12/11, 20093 EXP.12/13, 20092 EXP.12/13, 20091 EXP.12/13, 20085 EXP.12/13, 20084 EXP.12/13, 20083 EXP. 2/13, 20082 EXP.12/13, 20073 EXP. 12/13, 20074 EXP. 12/13, 20075 EXP. 12/13, 20081 EXP.12/13, 20021 EXP. 12/13
- Postal code
- 06320-5313
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1076-2014
- Classification
- Class II
- Recalling firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
- Product quantity
- 332508
- Termination date
- Jun 9, 2014
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 22, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 5, 2014