Home / Recalls / Franck's Lab Inc., d.b.a. Franck's Compounding Lab / D-1541-2012

D-1541-2012 Class II Terminated

Recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab — Ocala, FL

FDA drug recall D-1541-2012 was initiated by Franck's Lab Inc., d.b.a. Franck's Compounding Lab on May 25, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence o… The recall status is terminated (terminated August 13, 2014). Affected quantity: 7 units.

Recall Details

Product Type
Drugs
Report Date
August 22, 2012
Initiation Date
May 25, 2012
Termination Date
August 13, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7 units

Product Description

HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1500MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% SODIUM CHLORIDE) 50MG/500MCG/7.5MG/ML I 18 ML (3 DIFFEENT PRODUCTS)

Reason for Recall

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Distribution Pattern

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

Code Information

Rx #'s:N0391871 N0395248 N0400014 N0404731 N0404936 N0408940 N0387888

Other recalls by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

  • D-1479-2012 Class II — BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT) (May 25, 2012)
  • D-1531-2012 Class II — HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM** (May 25, 2012)
  • D-1516-2012 Class II — ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, (May 25, 2012)
  • D-1491-2012 Class II — CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALMIC (May 25, 2012)
  • D-1478-2012 Class II — BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/ (May 25, 2012)
  • D-1522-2012 Class II — FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 30MG (May 25, 2012)
  • D-1468-2012 Class II — BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT (May 25, 2012)
  • D-1481-2012 Class II — CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) (May 25, 2012)
  • D-1494-2012 Class II — CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) (May 25, 2012)
  • D-1460-2012 Class II — BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR (May 25, 2012)

FDA data resources