Multi-event November 2022 FDA Recall Drug by Nephron Sterile Compounding Center Llc

This Multi-event Class II drug recall was voluntarily initiated by Nephron Sterile Compounding Center Llc on November 10, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0065-2023 TERMINATED D-0064-2023 TERMINATED

Recall Number: D-0065-2023

Reason for Recall
CGMP Deviations: Potential for cross contamination due to product carry over.
Initiated
11-10-2022
Reported
11-23-2022
Quantity
56,220 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91132
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Nephron Sterile Compounding Center LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2024
Product Description About Product Description
Full technical description of the product.
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.

Batch or Lot Expiration Information

Lot# Lots: NE1062A, NE1062B Exp. 12/02/2022; NE1065A, NE1065B Exp. 12/13/2022; NE2011A, NE2011B Exp. 03/15/2022.

Recall Number: D-0064-2023

Reason for Recall
CGMP Deviations: Potential for cross contamination due to product carry over.
Initiated
11-10-2022
Reported
11-23-2022
Quantity
34,020 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91132
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Nephron Sterile Compounding Center LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2024
Product Description About Product Description
Full technical description of the product.
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.

Batch or Lot Expiration Information

Lot# Lots: LB2001B Exp. 01/07/2023; LB2005B Exp. 03/02/2023