Recalls / Class I
Class ID-0839-2018
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 3.375 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 60505-0687-4
- Affected lot / code info
- Lots: 501G014 Exp. 05/2018; 501G015 Exp.09/2018; 501G016, 501G017, 501G018, 501G019, 501G020, 501G021, 501G022, 501G023 Exp. 10/2018; 501G024, 501G025, 501G026, 501G027, 501G028, 501G029 501G030, Exp. 11/2018, 501H001, 501H002, 501H003, 501H004, 501H005, 501H006, 501H007, 501H008, Exp. 12/2018; 501H009, Exp. 04/2019; 501H012, 501H013 Exp. 06/2019; 501H018, 501H019, Exp. 09/2019.
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
- 121693 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-0839-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.