Home / Recalls / Wellness Pharmacy, Inc. / D-1035-2013

D-1035-2013 Class II Terminated

Recalled by Wellness Pharmacy, Inc. — Birmingham, AL

FDA drug recall D-1035-2013 was initiated by Wellness Pharmacy, Inc. on August 23, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's … The recall status is terminated (terminated June 3, 2014). Affected quantity: 1355 Vials.

Recall Details

Product Type
Drugs
Report Date
September 18, 2013
Initiation Date
August 23, 2013
Termination Date
June 3, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1355 Vials

Product Description

Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627

Reason for Recall

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot# 130605@52, Exp. 12/2/13

Other recalls by Wellness Pharmacy, Inc.

  • D-1033-2013 Class II — NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PH (August 23, 2013)
  • D-1032-2013 Class II — Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, (August 23, 2013)
  • D-1034-2013 Class II — RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNES (August 23, 2013)
  • D-1030-2013 Class II — Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627 (August 23, 2013)
  • D-1031-2013 Class II — Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHA (August 23, 2013)

FDA data resources