Recalls / Class II
Class IID-0220-2018
Product
ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12, Rx Only, PharMEDium Services, LLC, 913 N. Davis Ave, Cleveland, MS, Code 2R3304.
- Affected lot / code info
- Lot #: 172950036M, Exp. 1/21/2018; 172940003M, Exp. 1/20/2018; 172880044M, Exp. 1/14/2018; 172840176M, Exp. 1/11/2018; 172920115M, Exp. 1/18/2018; 172840015D, Exp. 1/10/2018; 172930139M, Exp. 1/19/2018.
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 5002 syringes
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2017-10-30
- FDA classified
- 2018-01-12
- Posted by FDA
- 2018-01-24
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0220-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.