Multi-event November 2013 FDA Recall Sheffield Triple Antibiotic by Faria Limited Llc Dba Sheffield Pharmaceuticals
This Multi-event Class II drug recall was voluntarily initiated by Faria Limited Llc Dba Sheffield Pharmaceuticals on November 22, 2013 for the product Sheffield Triple Antibiotic. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1077-2014
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
11-22-2013
02-12-2014
147566
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Faria Limited LLC dba Sheffield Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
06-09-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105
Batch or Lot Expiration Information
Lot# 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
Recall Number: D-1078-2014
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
11-22-2013
02-12-2014
26424
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Faria Limited LLC dba Sheffield Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
06-09-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072
Batch or Lot Expiration Information
Lot# 20221 EXP. 04/14
Recall Number: D-1076-2014
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
11-22-2013
02-12-2014
332508
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Faria Limited LLC dba Sheffield Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
06-09-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 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
