Recalls / Class I
Class ID-806-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
- Affected lot / code info
- Lot #: 503B015, 503B016, Exp 04/13; 503B019, 503B020, 503B021, 503B022, Exp 07/13; 503B024, Exp 08/13; 503B025, 503B026, 503B027, Exp 09/13; 503C005, 503C006, Exp 12/13; 503C007, 503C008, Exp 01/14; 503C018, Exp 04/14
Why it was recalled
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 37,303 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-03-18
- FDA classified
- 2013-07-17
- Posted by FDA
- 2013-07-24
- Terminated
- 2018-01-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-806-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.