Injectable Bupivacaine Recalled Due to Manufacturing Cross-Contamination Risk
Nephron Sterile Compounding Center is recalling 2,030 bags of injectable bupivacaine due to potential cross-contamination from manufacturing process defects. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II injectable drug with potential cross-contamination risk from manufacturing defects. The hazard is theoretical with no reported illnesses or injuries, meeting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling PF-0.125% Bupivacaine HCl Injection (1.25 mg/mL, 500 mL bags) distributed nationwide in the United States. The recall involves 2,030 bags packaged in 10 x 1 bag cases, with lot numbers BH2003A (expiration 8/19/2022) and BH2011A (expiration 11/9/2022).
The recall was initiated due to Good Manufacturing Practice (CGMP) deviations that created a potential for cross-contamination of the product during manufacturing. Specifically, there is a risk of product carryover from one batch to another during the production process, which could contaminate the affected lots.
No illnesses or injuries have been reported in connection with this product. Healthcare providers should immediately discontinue use of affected lots and quarantine or return the product. Patients who received injections from these lots should contact their healthcare provider if they experience any unusual symptoms.
The recalled product
- Product
- PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable / IV Solution
- Hazard
- cross-contamination
- cgmp-deviation
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 (4)
- Lots: BH2003A
- Exp. 8/19/2022
- BH2011A
- Exp. 11/9/2022
Distribution
Distributed nationwide across the United States.
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