FDA Recall D-0867-2020
RemedyRepack Inc. · Indiana, PA
Class I — life-threatening Terminated 235 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00
Reason for recall
Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
Recall record
- Recall number
D-0867-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product distributed in OK and LA.
- Recall initiated
- 2019-12-27
- Classified by FDA Center
- 2020-03-03
- FDA published
- 2020-02-19
- Terminated
- 2020-08-18
- Recalling firm
- RemedyRepack Inc.
- Firm location
- Indiana, PA