Recalls / Class II
Class IID-0484-2015
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
- NDC 61786-0055-01, Lot # B00484449-100914, Lot # B0062349-121914, Lot # B006655-011415; Expiration Date: 04/01/2016
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 vials
- Distribution pattern
- PA, OK.
Timeline
- Recall initiated
- 2015-02-18
- FDA classified
- 2015-04-09
- Posted by FDA
- 2015-04-15
- Terminated
- 2015-08-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0484-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.