Recalls / Class II
Class IID-1044-2018
Product
5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
- Affected lot / code info
- Lot 181730039D, Exp 09/20/2018
Why it was recalled
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Recalling firm
- Firm
- PharMEDium Services, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 36 Stults Rd, N/A, Dayton, New Jersey 08810
Distribution
- Quantity
- 450 Syringes
- Distribution pattern
- Product was distributed throughout the United States
Timeline
- Recall initiated
- 2018-07-24
- FDA classified
- 2018-08-03
- Posted by FDA
- 2018-08-15
- Terminated
- 2018-12-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1044-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.