Thiamine HCl Injection — Class III drug recall D-0601-2021
Terminated recall by Mylan Institutional LLC, reported 2021-06-09, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials l
| Recall number | D-0601-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional LLC, Rockford, IL, United States |
| Recall initiated | 2021-05-03 |
| Classified | 2021-06-01 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2022-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 2,131 cartons |
| Reason classes | labeling |
| NDC | 67457-0196, 67457-0196-00, 67457-0196-02 |
| Lot numbers | 200906 |
| Expiration dates | 2022-02-20 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0601-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.