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.
Reported: September 28, 2016 Initiated: August 24, 2016 #D-1513-2016
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Details
- Recalling Firm
- Sandoz Inc
- Units Affected
- 32,099 cartons
- Distribution
- Nationwide and Puerto Rico
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sandoz Inc. Units affected: 32,099 cartons.
Why was this product recalled? ▼
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 28, 2016. Severity: Moderate. Recall number: D-1513-2016.
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