Why it was 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.
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
Lot numbers, UPCs & expiration codes
Lot #: 200906, Exp. Date February 2022
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0601-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 3, 2021
- FDA report date
- Jun 9, 2021
- Quantity
- 2,131 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional LLC
Original FDA data
Every field from FDA enforcement report D-0601-2021, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 87803
- Address
- 4901 Hiawatha Dr
- Code information
- Lot #: 200906, Exp. Date February 2022
- Postal code
- 61103-1287
- Report date
- Jun 9, 2021
- Product type
- Drugs
- Recall number
- D-0601-2021
- Classification
- Class III
- Recalling firm
- Mylan Institutional LLC
- Product quantity
- 2,131 cartons
- Termination date
- Oct 18, 2022
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 3, 2021
- Initial firm notification
- Letter
- Center classification date
- Jun 1, 2021