Ketorolac Tromethamine Injection
FDA Recall NDC 0641-6041
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Ketorolac Tromethamine (NDC 0641-6041). A significant event, classified as Class II, was initiated on Dec 17, 2019 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Dec 17, 2019
Jan 22, 2020
25,817 shelf packs/25 vials per pack
Recall Profile & Regulatory Data
Event ID
84534
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jun 09, 2021
Product Description
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Batch or Lot Expiration Information
Lot# 038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020
Affected Packages Involved in this Recall
0641-6043-01Product
0641-6043-25Product
0641-6042-01Product
0641-6042-25Product
0641-6041-01Product
0641-6041-25Product
Class I Terminated
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Dec 17, 2019
Jan 22, 2020
101,710 25 vials/shelf-pack
Recall Profile & Regulatory Data
Event ID
84534
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jun 09, 2021
Product Description
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Batch or Lot Expiration Information
Lot# : 038366, Exp. Date Mar 2020; 048365, 048367, Exp. Date Apr 2020; 078301, 078303, Exp. Date July 2020; 118358, Exp. Date Nov 2020; 029353, Exp. Date Feb 2021; 019413, Exp. Date Jan 2021
Affected Packages Involved in this Recall
0641-6043-01Product
0641-6043-25Product
0641-6042-01Product
0641-6042-25Product
0641-6041-01Product
0641-6041-25Product
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.
