FDA Drug recall D-0864-2020
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-2…
- FDA Drug
- Class I
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class I recall of Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-2… 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-0864-2020 |
| Classification | Class I |
| 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 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.
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 | Lot #: 038366, Exp. Date Mar 2020; 048365, 048367, Exp. Date Apr 2020; 078301, 078303, Exp. Date July 2020; 118358, Exp…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 |
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-0864-2020%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.