Faria Limited LLC dba Sheffield Pharmaceuticals: 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 Londo

Is my product affected?

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

• Brand SHEFFIELD TRIPLE ANTIBIOTIC

Check against the official notice below — it lists the full affected range.

What happened

Dr. Sheffield Triple Antibiotic Ointment sold by Sheffield Pharmaceuticals has been recalled nationwide due to microbial contamination. Environmental testing found elevated counts of gram positive rods in the product. The recall affects two sizes: the 0.33 oz (9g) tube and the 1 oz (22g) tube, with approximately 332,508 units involved across multiple lot numbers with expiration dates ranging from December 2011 to December 2013.

The affected lot numbers are: 20154, 20153, 20152, 20151, 20093, 20092, 20091, 20085, 20084, 20083, 20082, 20073, 20074, 20075, 20081, and 20021. The recall source does not specify what action consumers should take regarding affected products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

Details from the source

Reason for recall: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing Distribution: Nationwide Quantity: 332508 Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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