Reported Oct 4, 2017 · Terminated
Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and…
RemedyRepack Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RemedyRepack Inc. · 625 Kolter Dr Ste 4 · Indiana, PA · 15701-3571
Is this the product you have?
Ketorolac Trom 30 mg/mL Injectionpackaged in a) 1 mL vials
- NDC 61786-0741-01 (Orig00548-9021-00)
- Ref33631 and b) 10 x 1 mL vials per tray
- NDC 61786-0741-08 (Orig00548-9021-00)
- Ref33632, Rx only
- Packaged byRemedyRepack Inc, Indiana, PA 15704
- Mfg byAmphastar, Rancho Cucamonga, CA 91730
- Lot codes and dates
- Lot #:
- a) B0158730-060816 (MfgXI002A6)
- Exp12/2017
- and b) B0160669-061516 (Mfg
XI003A6)Exp 12/2017
- Amount recalled
- 40 vials
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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