D-0867-2020 Class I Terminated
FDA drug recall D-0867-2020 was initiated by RemedyRepack Inc. on December 27, 2019 and is designated Class I. 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. The recall status is terminated (terminated August 18, 2020). Affected quantity: 75 1 ml vials.
Recall Details
- Product Type
- Drugs
- Report Date
- February 19, 2020
- Initiation Date
- December 27, 2019
- Termination Date
- August 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 1 ml vials
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.
Distribution Pattern
Product distributed in OK and LA.
Code Information
Lot # B0444562-060118, exp. 04/2020, B0537002-112118, exp 07/2020