Class II
Terminated
LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.00025%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.0005%/0.25% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML (8 DIFFERENT PRODUCTS)
This recall has been terminated (originally issued August 22, 2012).
- Recall Initiated
- May 21, 2012
- Posted
- August 22, 2012
- Recall Number
- D-1561-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11 units
- Firm Location
- Ocala, FL, United States
- Official Source
- View on FDA website ↗
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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Lot / Code Info
Rx #'s: 0370173 0370173 0370173 0370173 0371532 0371532 0371532 0371532
More recalls by Franck'S Lab Inc., D.B.A. Franck'S Compounding Lab
FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT)
Aug 22, 2012 · Class II
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