Why it was recalled
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Product description
FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105
Lot numbers, UPCs & expiration codes
20022 EXP. 12/13, 20031 EXP. 12/13, 20032 EXP. 12/13, 20041 EXP. 12/13, 20042 EXP. 12/13, 20051 EXP. 12/13, 20052 EXP. 12/13, 20061 EXP. 12/13, 20071 EXP. 12/13, 20072 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-1077-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 22, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 147566
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1077-2014, 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
- 20022 EXP. 12/13, 20031 EXP. 12/13, 20032 EXP. 12/13, 20041 EXP. 12/13, 20042 EXP. 12/13, 20051 EXP. 12/13, 20052 EXP. 12/13, 20061 EXP. 12/13, 20071 EXP. 12/13, 20072 EXP. 12/13
- Postal code
- 06320-5313
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1077-2014
- Classification
- Class II
- Recalling firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
- Product quantity
- 147566
- 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
- FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 22, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 5, 2014