Recalls / Class II
Class IID-1497-2014
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.
- Affected lot / code info
- Lot # 14C24-U04-018189; Exp. 03/17 Lot # 14C26-U02-018214; Exp. 03/17
Why it was recalled
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Recalling firm
- Firm
- Fagron, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 Pilot Knob Rd, Saint Paul, Minnesota 55120-1118
Distribution
- Quantity
- 97 jars
- Distribution pattern
- Nationwide and Australia
Timeline
- Recall initiated
- 2014-07-24
- FDA classified
- 2014-07-30
- Posted by FDA
- 2014-08-06
- Terminated
- 2014-10-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1497-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.