Why it was recalled
Presence of Particulate Matter: Found during examination of retention samples.
Product description
Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.
Lot numbers, UPCs & expiration codes
Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13
Where it was sold
Nationwide
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-832-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 20, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 1,635 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Incorporated
Original FDA data
Every field from FDA enforcement report D-832-2013, exactly as published.
Show all FDA fields
- City
- Broomfield
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 65200
- Address
- 2555 W Midway Blvd
- Code information
- Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13
- Postal code
- 80020-1632
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-832-2013
- Classification
- Class I
- Recalling firm
- Sandoz Incorporated
- Product quantity
- 1,635 vials
- Termination date
- Jan 29, 2014
- Reason for recall
- Presence of Particulate Matter: Found during examination of retention samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 20, 2013
- Initial firm notification
- Press Release
- Center classification date
- Aug 2, 2013