FDA Drug recall D-0286-2021
Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose V…
- FDA Drug
- Class I
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class I recall of Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose V… by Meitheal Pharmaceuticals, citing labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed t….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0286-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-01-27 |
| Published | 2021-03-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Meitheal Pharmaceuticals |
| Distribution | US |
Product
Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631.
Reason
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
Identifiers
| ndc | 71288-712-05 |
|---|---|
| ndc | 71288-712-06 |
| ndc | 71288-714-10 |
| ndc | 71288-714-11 |
| ndc | 71288-713-20 |
| ndc | 71288-713-21 |
| code_info | Lot C11507A |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0286-2021%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.