FDA Drug recall D-0658-2020
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 (ND…
- FDA Drug
- Class II
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class II recall of 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 (ND… by Hikma Pharmaceuticals Usa, citing presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0658-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-17 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Pharmaceuticals Usa |
| Distribution | US |
Product
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.
Reason
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Identifiers
| ndc | 0641-6043-01 |
|---|---|
| ndc | 0641-6043-25 |
| ndc | 0641-6042-01 |
| ndc | 0641-6042-25 |
| ndc | 0641-6041-01 |
| ndc | 0641-6041-25 |
| code_info | 038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Hikma Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0658-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.