Recall record at a glance
| Official record | D-0868-2016 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Teva North America |
| Report date | Jun 1, 2016 |
| Recall initiation date | Apr 27, 2016 |
| Quantity | 546 bags |
| Location | Horsham, PA, United States |
Official 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
Why the product was recalled
Lack of Assurance of Sterility: Due to potential for leaking bags.
Distribution information
Nationwide
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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