CLASS II Drug recall · Reported 15 Apr 2015 · FDA Enforcement Report
Ketorolac Trom 30 MG/ML Inj glass recalled by RemedyRepack
RemedyRepack is recalling Ketorolac Trom 30 MG/ML Inj glass, distributed in Oklahoma, Pennsylvania. The recall was initiated on 18 Feb 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0484-2015
- FDA event ID
- 70549
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Feb 2015
- FDA classified
- 9 Apr 2015
- Reported
- 15 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 18 Feb 2015 | Recall initiated by company | |
| 9 Apr 2015 | Classified by FDA | +50 days |
| 15 Apr 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
PA, OK.
Questions about this recall
Why was it recalled?
Crystallization
Which lots are affected?
NDC 61786-0055-01, Lot # B00484449-100914, Lot # B0062349-121914, Lot # B006655-011415; Expiration Date: 04/01/2016
Where was it sold?
PA, OK.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from RemedyRepack
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack | RemedyRePack | Manufacturing (CGMP) Deviations | FL, PA, VA |
| Drug | CLASS II | Clindamycin HCl, QTY recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Carvedilol, QTY: per Blister Pack ( blister cards) recalled | RemedyRepack | Nitrosamine Impurity | FL |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled | RemedyRepack | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Potassium Chloride Micro 10mEq recalled by RemedyRepack | RemedyRepack | Potency & Assay | Nationwide |
Other Ketorolac Trom recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Ketorolac Trom, 30 mg/ Inj recalled by RemedyRepack | RemedyRepack | Particulate Matter | LA, OK |
| Drug | CLASS II | Ketorolac Trom 30 mg/mL Injection recalled by RemedyRepack | RemedyRepack | Particulate Matter | LA |
| Drug | CLASS II | Ketorolac Trom 30 MG/ML Inj glass recalled by RemedyRepack | RemedyRepack | Foreign Material | OK, PA |