PF-Labetalol HCl Injection recall: CGMP Deviations
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
Why was PF-Labetalol HCl Injection recalled?
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: LB2005A, Exp 3/2/2023
- Product
- PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Quantity
- 33,870 vials
- Distribution
- Nationwide in the USA
- Recall date
- August 24, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)