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
Reported: June 9, 2021 Initiated: May 3, 2021 #D-0601-2021
Product Description
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.
Details
- Recalling Firm
- Mylan Institutional LLC
- Units Affected
- 2,131 cartons
- Distribution
- Nationwide within the United States
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mylan Institutional LLC. Units affected: 2,131 cartons.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 9, 2021. Severity: Low. Recall number: D-0601-2021.
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