NDC 84549-701
Ketorolac Tromethamine 30 mg per 1 mL injection, solution
On the label: ProPharma Distribution. It's repackaged: ProPharma Distribution rebottles it from Sagent Pharmaceuticals's NDC 25021-701.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Sagent Pharmaceuticals names for other drugs.
Repackaging site
- ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it
Recalls
- Apr 30, 2019 · Class II · Sagent Pharmaceuticals Inc
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Lots: Lot #: M813513, Exp. Feb 2020 - Oct 3, 2014 · Class II · Sagent Pharmaceuticals Inc
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
Lots: Lot MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ketorolac: every company that makes it
- Form
- injection, solution, intramuscular; intravenous
- Strength
- 30 mg per 1 mL
- Approval
- ANDA ANDA204216
- On the market since
- Sep 5, 2014
- Package NDCs
84549-701-01- Official label
- DailyMed (National Library of Medicine), updated Sep 18, 2025
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