Why it was recalled
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Product description
EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6119, NDC# 61553-119-61.
Lot numbers, UPCs & expiration codes
Lot #: 15033030S, 15033031S, Exp 04/26/15; 15026051S, Exp 05/03/15
Where it was sold
Nationwide
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-1358-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 13, 2015
- FDA report date
- Sep 2, 2015
- Quantity
- 264 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-1358-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71846
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot #: 15033030S, 15033031S, Exp 04/26/15; 15026051S, Exp 05/03/15
- Postal code
- 60045-2506
- Report date
- Sep 2, 2015
- Product type
- Drugs
- Recall number
- D-1358-2015
- Classification
- Class I
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 264 bags
- Termination date
- Jan 23, 2017
- Reason for recall
- Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6119, NDC# 61553-119-61.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 13, 2015
- Initial firm notification
- Center classification date
- Aug 25, 2015