Recalls / Class II
Class IID-1064-2017
Product
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15
- Affected lot / code info
- Lot #: 9904, 9914, 9939, BUD: 7/28/2017; 9952, 9969, 10004, BUD: 8/4/2017; 10043, 10088, 10115, BUD: 8/17/2017; 10269, BUD: 9/8/2017;10431, BUD: 9/23/2017; 10554, BUD: 10/27/2017
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
- 49666 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-1064-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.