Why it was recalled
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot 181730039D, Exp 09/20/2018
Where it was sold
Product was distributed throughout the United States
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-1044-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 450 Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PharMEDium Services, LLC
Original FDA data
Every field from FDA enforcement report D-1044-2018, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80638
- Address
- 36 Stults Rd
- Code information
- Lot 181730039D, Exp 09/20/2018
- Postal code
- 08810
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1044-2018
- Classification
- Class II
- Recalling firm
- PharMEDium Services, LLC
- Product quantity
- 450 Syringes
- Termination date
- Dec 10, 2018
- Reason for recall
- CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Product was distributed throughout the United States
- Recall initiation date
- Jul 24, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 3, 2018