The Recall Desk
ModerateFDA (Drugs)·D-1176-2017·Announced 2017-10-04

Ketorolac Injection Recalled for Visible Crystalline Particulate

RemedyRepack Inc. is recalling 40 vials of Ketorolac Trom 30 mg/mL Injection due to visible crystalline particulate.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves visible particulate without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

RemedyRepack Inc. is recalling 40 vials of Ketorolac Trom 30 mg/mL Injection. The product is packaged in 1 mL vials (NDC 61786-0741-01) and 10 x 1 mL vials per tray (NDC 61786-0741-08). The affected lots are B0158730-060816 and B0160669-061516, both with an expiration date of 12/2017.

The recall was initiated because of the presence of visible particulate in the vials, which has been identified as crystalline ketorolac calcium salt. The product was distributed to one consignee in Louisiana.

Healthcare providers and patients should stop using the affected product and contact RemedyRepack Inc. for further instructions.

The recalled product

Product
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, Ra
Manufacturer
RemedyRepack Inc.
Category
Drug — Injection
Hazard
Affected units
40

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: a) B0158730-060816 (Mfg: XI002A6)
  • Exp: 12/2017
  • and b) B0160669-061516 (Mfg: XI003A6)
  • Exp 12/2017

Distribution

Distributed in 1 state:

Related recalls

Same manufacturer · RemedyRepack Inc.

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