Why it was recalled
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
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.
Lot numbers, UPCs & expiration codes
Lot # 14C24-U04-018189; Exp. 03/17 Lot # 14C26-U02-018214; Exp. 03/17
Where it was sold
Nationwide and Australia
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1497-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2014
- FDA report date
- Aug 6, 2014
- Quantity
- 97 jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron, Inc
Original FDA data
Every field from FDA enforcement report D-1497-2014, exactly as published.
Show all FDA fields
- City
- Saint Paul
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 68896
- Address
- 2400 Pilot Knob Rd
- Code information
- Lot # 14C24-U04-018189; Exp. 03/17 Lot # 14C26-U02-018214; Exp. 03/17
- Postal code
- 55120-1118
- Report date
- Aug 6, 2014
- Product type
- Drugs
- Recall number
- D-1497-2014
- Classification
- Class II
- Recalling firm
- Fagron, Inc
- Product quantity
- 97 jars
- Termination date
- Oct 21, 2014
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Australia
- Recall initiation date
- Jul 24, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 30, 2014