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Class II: temporary or reversible health riskTerminated

RemedyRepack Ketorolac Trom 30 Mg/Ml Inj Recall

KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber g…

RemedyRepack Inc. · Indiana, PA

Risk level
Class II
Reported by FDA
May 13, 2015
Recall ID
D-0974-2015
Check your lot numberHow we source this data

Summary

RemedyRepack recalled Ketorolac Trom 30 Mg/Ml Inj starting Apr 23, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0974-2015 on May 13, 2015. Reason: Crystallization. Status: Terminated.

Why it was recalled

Crystallization

Product description

KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01

Lot numbers, UPCs & expiration codes

Lot # B0069266-013015, Lot # B0069264-013015, Lot # B0066712-011415, EXP DATE 9/01/2016

Where it was sold

PA and OK

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0974-2015
Classification
Class II
Status
Terminated
Recall initiated
Apr 23, 2015
FDA report date
May 13, 2015
Quantity
25
Recall type
Voluntary: Firm initiated
Recalling firm
RemedyRepack Inc.

Original FDA data

Every field from FDA enforcement report D-0974-2015, exactly as published.

Show all FDA fields
City
Indiana
State
PA
Status
Terminated
Country
United States
Event ID
71094
Address
625 Kolter Dr
Address (line 2)
Suite 4
Code information
Lot # B0069266-013015, Lot # B0069264-013015, Lot # B0066712-011415, EXP DATE 9/01/2016
Postal code
15701-3570
Report date
May 13, 2015
Product type
Drugs
Recall number
D-0974-2015
Classification
Class II
Recalling firm
RemedyRepack Inc.
Product quantity
25
Termination date
Aug 18, 2015
Reason for recall
Crystallization
Voluntary / mandated
Voluntary: Firm initiated
Product description
KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
Distribution pattern
PA and OK
Recall initiation date
Apr 23, 2015
Initial firm notification
Letter
Center classification date
May 1, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0974-2015, published May 13, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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