Drug product
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.
D-1497-2014
Product summary
- Firm
- Fagron, Inc
- Event
- Event 68896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 97 jars
- Official record key
drug-enforcement:D-1497-2014
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Code information: Lot # 14C24-U04-018189; Exp. 03/17 Lot # 14C26-U02-018214; Exp. 03/17
Distribution pattern: Nationwide and Australia
Derived failure modes
-
Microbial contamination
Microbial Contamination