Home / Recalls / Fagron, Inc / D-1496-2014

D-1496-2014 Class II Terminated

Recalled by Fagron, Inc — Saint Paul, MN

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
430 jars

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.

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 # 13J30-U17-015413; Exp 10/15 Lot # 13J30-U16-015425; Exp 10/15 Lot # 13I06-U05-014199; Exp 10/15

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  • D-0156-2024 Class II — NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, (December 11, 2023)
  • D-0154-2024 Class II — NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, F (December 11, 2023)
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  • D-0866-2022 Class III — Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription (March 4, 2022)
  • D-0864-2022 Class III — Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription (March 4, 2022)
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