Status
Terminated
Drug Enforcement D-1498-2012
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
- DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1 PRODUCT) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE 0.05 ML 1 ML 16 ML 2 ML 24 ML 3 ML 32 ML 8 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 4MG/ML (0.4%) INJECTABLE 0.4 ML 2 ML 3 ML 5 ML 6 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 80MG/ML (8%) INJECTABLE 100 ML 40 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 8MG/ML (800MCG/0.1ML) INJECTABLE 0.1 ML DEXAMETHASONE SODIUM PHOSPHATE 40MG/ML INJECTABLE 50 ML DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE 100 ML 180 MLS 240 MLS 30 ML 60 ML DEXAMETHASONE SODIUM PHOSPHATE IN BSS (P.F.) 10MG/ML (1%) INJECTABLE 1 ML DEXAMETHASONE SODIUM PHOSPHATE, 30ML VIAL** 4MG/ML INJECTABLE 30 ML DEXAMETHASONE SOLUTION - NACL, P.F. 0.1% OPHTHALMIC 15 ML DEXAMETHASONE, SDPF - (0.07ML SYRINGE, 30G, 1/2") 80MG/ML INJECTABLE 0.35 ML 0.7 ML
- Product quantity
- 1 unit
- 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-1498-2012
- Event ID
- 62416
- Recall initiation date
- May 25, 2012
- Center classification date
- August 10, 2012
- Code info
- Rx #: 0400257
- More code info
- —