Why it was recalled
Lack of Assurance of Sterility: Due to potential for leaking bags.
Product description
Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454
Lot numbers, UPCs & expiration codes
Lot # 2520715, Exp Date: 7/17
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-0868-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 27, 2016
- FDA report date
- Jun 1, 2016
- Quantity
- 546 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva North America
Original FDA data
Every field from FDA enforcement report D-0868-2016, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 74180
- Address
- 425 Privet Rd
- Code information
- Lot # 2520715, Exp Date: 7/17
- Postal code
- 19044-1220
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0868-2016
- Classification
- Class II
- Recalling firm
- Teva North America
- Product quantity
- 546 bags
- Termination date
- Feb 5, 2018
- Reason for recall
- Lack of Assurance of Sterility: Due to potential for leaking bags.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 27, 2016
- Initial firm notification
- Letter
- Center classification date
- May 24, 2016