Status
Terminated
Drug Enforcement D-1459-2012
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.
Classification
Class II
Report Date
August 22, 2012
Termination Date
August 13, 2014
Product Information
- 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)
- Product quantity
- 21 units
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Location & Firm
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Address
-
1210 SW 33rd Avenue
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1459-2012
- Event ID
- 62416
- Recall initiation date
- May 25, 2012
- Center classification date
- August 10, 2012
- Code info
- Rx #'s: 0406446, 0404313, 0381309, 0390603, 0350228, 0389240, 0365111, 0383582, 0391840, 0399130, 0372385, 0387886, 0406914
- More code info
- —