Why it was recalled
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Product description
Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Lot numbers, UPCs & expiration codes
Lot Numbers: 170100124S, 4/11/2017; 170390015S, 5/10/2017
Where it was sold
Nationwide in the USA
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-0912-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 17, 2017
- FDA report date
- Jun 21, 2017
- Quantity
- 48 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0912-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77191
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot Numbers: 170100124S, 4/11/2017; 170390015S, 5/10/2017
- Postal code
- 60045-2506
- Report date
- Jun 21, 2017
- Product type
- Drugs
- Recall number
- D-0912-2017
- Classification
- Class III
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 48 bags
- Termination date
- Jun 13, 2017
- Reason for recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 17, 2017
- Initial firm notification
- Telephone
- Center classification date
- Jun 12, 2017