FDA Drug recall D-0601-2021
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…
- FDA Drug
- Class III
- terminated
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class III recall of 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… by Mylan Institutional, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0601-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-05-03 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Institutional |
| Distribution | US |
Product
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; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02
Reason
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.
Identifiers
| ndc | 67457-196-00 |
|---|---|
| ndc | 67457-196-02 |
| code_info | Lot #: 200906, Exp. Date February 2022 |
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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FDA Drug · Class II · 2024-12-18 · Mylan Institutional
All Mylan Institutional recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0601-2021%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.