Recalls / Class I
Class ID-0840-2018
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 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
- Affected lot / code info
- Lots: 502H001 Exp. 01/2019; 502H003, 502H004, 502H005, Exp. 04/2019; 502H009, 502H012, Exp. 05/2019.
Why it was recalled
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Dr, North York, N/A, Canada
Distribution
- Quantity
- 13453 vials
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-05-08
- FDA classified
- 2018-06-05
- Posted by FDA
- 2018-05-23
- Terminated
- 2023-10-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0840-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.