Home / Recalls / Franck's Lab Inc., d.b.a. Franck's Compounding Lab / D-1478-2012

D-1478-2012 Class II Terminated

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

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
16 units

Product Description

BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 35 ML (4 DIFFERENT 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:N0396140 N0408047 N0390990 N0400772 N0387610 N0391586 N0393141 N0396643 N0398235 N0402376 N0404186 N0409166 N0410206 N0387612 N0394426 N0402375

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

  • D-1530-2012 Class II — GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (May 25, 2012)
  • D-1541-2012 Class II — HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL (May 25, 2012)
  • D-1501-2012 Class II — DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTA (May 25, 2012)
  • D-1481-2012 Class II — CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) (May 25, 2012)
  • D-1496-2012 Class II — DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT) (May 25, 2012)
  • D-1521-2012 Class II — FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT) (May 25, 2012)
  • D-1504-2012 Class II — DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 (May 25, 2012)
  • D-1532-2012 Class II — HUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (1 PRODUCT) (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-1468-2012 Class II — BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT (May 25, 2012)