Home / Recalls / Franck's Lab Inc., d.b.a. Franck's Compounding Lab / D-1459-2012

D-1459-2012 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
21 units

Product Description

BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 600MCG/ML INTRATHECAL 40 ML; BACLOFEN, P.F. 1,000MCG/ML (1MG/ML) INTRATHECAL 20 ML, 40 ML; BACLOFEN, P.F. 500MCG/ML (0.5MG/ML) INTRATHECAL 40 ML; BACLOFEN, PRESERVATIVE FREE 3000MCG/ML INJECTABLE 40 ML; BACLOFEN, PRESERVATIVE FREE 3300MCG/ML(3.3MG/ML) INTRATHECAL 20 ML; BACLOFEN, PRESERVATIVE FREE 5000MCG/ML(5MG/ML) INTRATHECAL 40 ML (8 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: 0406446, 0404313, 0381309, 0390603, 0350228, 0389240, 0365111, 0383582, 0391840, 0399130, 0372385, 0387886, 0406914

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

  • D-1527-2012 Class II — G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS) (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-1453-2012 Class II — ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALT (May 25, 2012)
  • D-1541-2012 Class II — HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL (May 25, 2012)
  • D-1512-2012 Class II — EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DI (May 25, 2012)
  • D-1533-2012 Class II — HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID S (May 25, 2012)
  • D-1448-2012 Class II — ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT) (May 25, 2012)
  • D-1485-2012 Class II — CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS) (May 25, 2012)
  • D-1481-2012 Class II — CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) (May 25, 2012)
  • D-1492-2012 Class II — CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 (May 25, 2012)