FDAFDA · Food and drugs·Recall number D-1176-2017
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.
Published October 4, 2017 · Recall initiated: August 22, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RemedyRepack Inc.
- Distributor
- Product was distributed to one consignee in Louisiana.
- Lot
- Lot #: a) B0158730-060816 (Mfg: XI002A6), Exp: 12/2017 ; and b) B0160669-061516 (Mfg: XI003A6), Exp 12/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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