Why it was recalled
Subpotent Drug
Product description
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide within the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0220-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 30, 2017
- FDA report date
- Jan 24, 2018
- Quantity
- 5002 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0220-2018, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78683
- Address
- 150 N Field Dr Ste 350
- Code information
- 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.
- Postal code
- 60045-2506
- Report date
- Jan 24, 2018
- Product type
- Drugs
- Recall number
- D-0220-2018
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 5002 syringes
- Termination date
- May 7, 2020
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the US
- Recall initiation date
- Oct 30, 2017
- Initial firm notification
- Telephone
- Center classification date
- Jan 12, 2018