Why it was recalled
Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
Product description
Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-836-11, Service Code 2K5836.
Lot numbers, UPCs & expiration codes
Lot# 161300033M, Exp 07/26/16
Where it was sold
NY
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-0976-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 16, 2016
- FDA report date
- Jun 15, 2016
- Quantity
- 240 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0976-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 74299
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot# 161300033M, Exp 07/26/16
- Postal code
- 60045-2506
- Report date
- Jun 15, 2016
- Product type
- Drugs
- Recall number
- D-0976-2016
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 240 bags
- Termination date
- Jun 22, 2016
- Reason for recall
- Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-836-11, Service Code 2K5836.
- Distribution pattern
- NY
- Recall initiation date
- May 16, 2016
- Initial firm notification
- Telephone
- Center classification date
- Jun 9, 2016