Recalls / Class II
Class IID-1061-2017
Product
Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12
- Affected lot / code info
- Lot #: 9906, 9915 BUD: 7/28/2017; 9950, 9984, 10001,10010, BUD: 8/4/2017; 10064, BUD: 8/17/2017; 10341, 10452 BUD: 9/23/2017,
Why it was recalled
Lack of Sterility Assurance.
Recalling firm
- Firm
- Cantrell Drug Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7321 Cantrell Rd, N/A, Little Rock, Arkansas 72207-4144
Distribution
- Quantity
- 24638 syringes
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2017-07-14
- FDA classified
- 2017-08-09
- Posted by FDA
- 2017-08-16
- Terminated
- 2020-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1061-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.