August 2022 FDA Recall Ketorolac Tromethamine by Nephron Sc Inc
D-1354-2022 - cGMP Deviations
This Class II drug recall was voluntarily initiated by Nephron Sc Inc on August 10, 2022 for the product Ketorolac Tromethamine. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1354-2022
cGMP Deviations: deviations leading to potential cross-contamination.
08-10-2022
08-24-2022
5040 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nephron Sc Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
09-24-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
Batch or Lot Expiration Information
Lot# : 023011 Exp 8/31/2022
