Class II · Moderate risk
Labetalol Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
PF-Labetalol HCl Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
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
Affected NDC
69374-0946-34
Compare with the code on your package — it is the most precise check available.
Drug: Labetalol
- Recalling firm
- Nephron Sterile Compounding Center LLC
- NDC code
- 69374-946-34
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1347-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Labetalol recalls
See all
Class II · Moderate risk
labetalol HCl 20 mg/4mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk
Labetalol HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Labetalol HCl Injection
Lack of Assurance of Sterility
Other recalls by Nephron Sterile Compounding Center LLC
All 2022 recalls
Class II · Moderate risk
Sodium Chloride Injection 9%
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Class II · Moderate risk
Phenylephrine HCl in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
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