Recalls / Class II
Class IID-0508-2019
Product
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407
- Affected lot / code info
- Lot: 20181812@2 BUD: 06/16/2019
Why it was recalled
Lack of assurance of sterility.
Recalling firm
- Firm
- US Compounding Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1270 Dons Ln, Conway, Arkansas 72032-4753
Distribution
- Quantity
- 1686 syringes
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-01-29
- FDA classified
- 2019-02-15
- Posted by FDA
- 2019-02-27
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0508-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.