Ketorolac Tromethamine Injection, Solution
FDA Recall NDC 31722-307
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ketorolac Tromethamine (NDC 31722-307). A significant event, classified as Class II, was initiated on Oct 01, 2025 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Presence of Particulate Matter: Particulate matter identified as glass"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Particulate Matter: Particulate matter identified as glass
Oct 01, 2025
Oct 29, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97711
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aspiro Pharma Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).
Batch or Lot Expiration Information
Lot# : AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.
Affected Packages Involved in this Recall
31722-305-25Product
31722-305-10Product
31722-306-25Product
31722-307-25Product
31722-307-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
