Medications & Supplements/Prescription Drugs

RemedyRepack Inc.: Ketorolac Injection Recalled for Crystalline Particle Contamination

Agency Publication Date: September 22, 2017

Summary

RemedyRepack Inc. is recalling 40 vials of Ketorolac Tromethamine (30 mg/mL) Injection due to the presence of visible particles identified as crystalline ketorolac calcium salt. This injectable medication, which is the generic version of Toradol, was repackaged from a manufacturer's lot that was also recalled for this defect. Consumers should not use the affected vials as injecting particles into the bloodstream can cause serious health complications. This product was distributed to a single location in Louisiana.

Risk

The presence of crystalline particles in an injectable drug can cause local irritation, swelling, or more serious issues like the blockage of blood vessels, which could lead to a stroke, heart attack, or damage to other organs.

What You Should Do

Check your medication for Ketorolac Trom 30 mg/mL Injection in 1 mL vials with NDC 61786-0741-01 (Ref: 33631) or 10-vial trays with NDC 61786-0741-08 (Ref: 33632).
Verify if your product matches Lot B0158730-060816 (Expiration: 12/2017) or Lot B0160669-061516 (Expiration: 12/2017).
Immediately stop using any vials from these specific lots and set them aside.
Contact your healthcare provider or pharmacist immediately for guidance on a replacement medication and to discuss any health concerns.
Return any unused product to the pharmacy or place of purchase for a refund.
Contact the manufacturer, RemedyRepack Inc., at their Indiana, PA facility for further instructions regarding this recall.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Manufacturer refund/return protocol.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ketorolac Trom 30 mg/mL Injection (1 mL vial)

Model:

Ref: 33631

NDC 61786-0741-01

Orig NDC 00548-9021-00

Lot Numbers:

B0158730-060816 (Mfg: XI002A6) (Exp: 12/2017)

Date Ranges: Expiration: 12/2017

Product: Ketorolac Trom 30 mg/mL Injection (10 x 1 mL vials per tray)

Model:

Ref: 33632

NDC 61786-0741-08

Orig NDC 00548-9021-00

Lot Numbers:

B0160669-061516 (Mfg: XI003A6) (Exp: 12/2017)

Date Ranges: Expiration: 12/2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78146

Status: Resolved

Manufacturer: RemedyRepack Inc.

Sold By: one consignee in Louisiana

Manufactured In: United States

Units Affected: 40 vials

Distributed To: Louisiana

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication for Ketorolac Trom 30 mg/mL Injection in 1 mL vials with NDC 61786-0741-01 (Ref: 33631) or 10-vial trays with NDC 61786-0741-08 (Ref: 33632).

Verify if your product matches Lot B0158730-060816 (Expiration: 12/2017) or Lot B0160669-061516 (Expiration: 12/2017).

Immediately stop using any vials from these specific lots and set them aside.

Contact your healthcare provider or pharmacist immediately for guidance on a replacement medication and to discuss any health concerns.

Return any unused product to the pharmacy or place of purchase for a refund.

Contact the manufacturer, RemedyRepack Inc., at their Indiana, PA facility for further instructions regarding this recall.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Ketorolac Trom 30 mg/mL Injection (1 mL vial)

Model:

Ref: 33631

NDC 61786-0741-01

Orig NDC 00548-9021-00

Lot Numbers:

B0158730-060816 (Mfg: XI002A6) (Exp: 12/2017)

Date Ranges: Expiration: 12/2017

Product: Ketorolac Trom 30 mg/mL Injection (10 x 1 mL vials per tray)

Model:

Ref: 33632

NDC 61786-0741-08

Orig NDC 00548-9021-00

Lot Numbers:

B0160669-061516 (Mfg: XI003A6) (Exp: 12/2017)

Date Ranges: Expiration: 12/2017