Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Rancho Cucamonga, CA 91730.
Reported: October 4, 2017 Initiated: August 22, 2017 #D-1176-2017
Product Description
Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Rancho Cucamonga, CA 91730.
Reason for Recall
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 40 vials
- Distribution
- Product was distributed to one consignee in Louisiana.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Rancho Cucamonga, CA 91730.. Recalled by RemedyRepack Inc.. Units affected: 40 vials.
Why was this product recalled? ▼
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 4, 2017. Severity: Moderate. Recall number: D-1176-2017.
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