D-1497-2014 Class II Terminated
FDA drug recall D-1497-2014 was initiated by Fagron, Inc on July 24, 2014 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. The recall status is terminated (terminated October 21, 2014). Affected quantity: 97 jars.
Recall Details
- Product Type
- Drugs
- Report Date
- August 6, 2014
- Initiation Date
- July 24, 2014
- Termination Date
- October 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97 jars
Product Description
Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.
Reason for Recall
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Distribution Pattern
Nationwide and Australia
Code Information
Lot # 14C24-U04-018189; Exp. 03/17 Lot # 14C26-U02-018214; Exp. 03/17