Recalls / Class II
Class IID-0974-2015
Product
KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
- Affected lot / code info
- Lot # B0069266-013015, Lot # B0069264-013015, Lot # B0066712-011415, EXP DATE 9/01/2016
Why it was recalled
Crystallization
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr, Suite 4, Indiana, Pennsylvania 15701-3570
Distribution
- Quantity
- 25
- Distribution pattern
- PA and OK
Timeline
- Recall initiated
- 2015-04-23
- FDA classified
- 2015-05-01
- Posted by FDA
- 2015-05-13
- Terminated
- 2015-08-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0974-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.