Recalls / Class II
Class IID-1513-2016
Product
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
- Affected lot / code info
- Lot #: 080514, 080614, 081114, 081214, 081314, 081414, 082714, 082814, 082914, Exp 08/16; 090214, 090314, 090814, 090914, 091014, 091114, 091214, 091514, Exp 09/16
Why it was recalled
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 32,099 cartons
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-08-24
- FDA classified
- 2016-09-19
- Posted by FDA
- 2016-09-28
- Terminated
- 2017-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1513-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.