Why it was recalled
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Product description
Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6.
Lot numbers, UPCs & expiration codes
Lot # 13J30-U17-015413; Exp 10/15 Lot # 13J30-U16-015425; Exp 10/15 Lot # 13I06-U05-014199; Exp 10/15
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-1496-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2014
- FDA report date
- Aug 6, 2014
- Quantity
- 430 jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron, Inc
Original FDA data
Every field from FDA enforcement report D-1496-2014, 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 # 13J30-U17-015413; Exp 10/15 Lot # 13J30-U16-015425; Exp 10/15 Lot # 13I06-U05-014199; Exp 10/15
- Postal code
- 55120-1118
- Report date
- Aug 6, 2014
- Product type
- Drugs
- Recall number
- D-1496-2014
- Classification
- Class II
- Recalling firm
- Fagron, Inc
- Product quantity
- 430 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, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6.
- Distribution pattern
- Nationwide and Australia
- Recall initiation date
- Jul 24, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 30, 2014