Recall of Mepivacaine Injectable Due to Sterility Assurance Failure
Franck's Lab Inc. is recalling sterile Mepivacaine HCL injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in injectable drugs, which poses a significant risk of infection or serious injury.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling specific sterile injectable drugs containing Mepivacaine HCL. The affected products include Mepivacaine HCL/Epinephrine 2%/1:100,000 (0.001%) Injectable in 30 mL and 60 mL vials, and Mepivacaine HCL 3% (30 mg/mL) Injectable in 6 mL vials. The recall covers units distributed between November 21, 2011, and May 21, 2012.
The recall was initiated due to a lack of assurance of sterility. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. The agency has classified this as a Class II recall.
The products were distributed nationwide and in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Consumers and healthcare providers should stop using these products and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- MEPIVACAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 30 ML 60 ML; MEPIVICAINE HCL 3% (30MG/ML) INJECTABLE 6 MLS (3 DIFFERENT PRODUCTS)
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Rx #'s: 0392297 0392297 0395407
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 98 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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