Drug 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.
D-1513-2016
Product summary
- Firm
- Sandoz Inc
- Event
- Event 75032
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,099 cartons
- Official record key
drug-enforcement:D-1513-2016
Official wording
Reason: Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Code information: Lot #: 080514, 080614, 081114, 081214, 081314, 081414, 082714, 082814, 082914, Exp 08/16; 090214, 090314, 090814, 090914, 091014, 091114, 091214, 091514, Exp 09/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility