Drug recall
Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per…
FDA recall event 87803 · Class III · Mylan Institutional LLC
Key facts
| Event ID | 87803 |
|---|---|
| Recall numbers | D-0601-2021 |
| Recalling firm | Mylan Institutional LLC |
| Product type | Drugs |
| Products | Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901. |
| Initiation date | May 3, 2021 |
| Report date | Jun 9, 2021 |
| Termination date | Oct 18, 2022 |
| City | Rockford |
| State | IL |
| Country | United States |
| FEI number | 3010547225 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: