August 2017 FDA Recall Drug by Amphastar Pharmaceuticals, Inc.
D-1124-2017 - Crystallization

This Class II drug recall was voluntarily initiated by Amphastar Pharmaceuticals, Inc. on August 15, 2017 for the product Drug. The FDA reported the reason for recall as crystallization. The product was distributed in Distributed throughout the United States and the recall is currently terminated.

Recall Number: D-1124-2017

Reason for Recall
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Initiated
08-15-2017
Reported
09-06-2017
Quantity
637,810 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77988
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.
Amphastar Pharmaceuticals, Inc.
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.
Distributed throughout the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-14-2019
Product Description About Product Description
Full technical description of the product.
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00

Batch or Lot Expiration Information

Lot# XI002A6, XI003A6, Exp 12/17; XI004G6, XI005G6, Exp 6/18; XI007H6, Exp 7/18; XI00816, XI00916, XI01016, XI01116, Exp 8/18; XI012J6, XI013J6, Exp 9/18; XI015K6, Exp 10/18; XI016L6, Exp 11/18; XL018A7, XI019A7, Exp 12/18; XI020B7, XI021B7, Exp 1/19; XI022C7, XI023C7, Exp 2/19; XI025D7, Exp 3/19.