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
Reported: February 19, 2020 Initiated: December 27, 2019 #D-0867-2020
Product Description
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.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 75 1 ml vials
- Distribution
- Product distributed in OK and LA.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by RemedyRepack Inc.. Units affected: 75 1 ml vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 19, 2020. Severity: Critical. Recall number: D-0867-2020.
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