Why it was recalled
Presence of particulate matter: glass
Product description
Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
Lot numbers, UPCs & expiration codes
Lot #: L200253, L200281, L200301, Exp 07/31/2024
Where it was sold
TN
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-0600-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 27, 2024
- FDA report date
- Jul 24, 2024
- Quantity
- 432250 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0600-2024, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 94914
- Address
- 73 Route 31 N
- Code information
- Lot #: L200253, L200281, L200301, Exp 07/31/2024
- Postal code
- 08534-3601
- Report date
- Jul 24, 2024
- Product type
- Drugs
- Recall number
- D-0600-2024
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 432250 vials
- Termination date
- Sep 4, 2025
- Reason for recall
- Presence of particulate matter: glass
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
- Distribution pattern
- TN
- Recall initiation date
- Jun 27, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 16, 2024