Class II · Moderate risk
fentaNYL Citrate Injection 50 mcg per mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Potassium CHLORide added to 5% Dextrose Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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.
Affected NDC
61553-0836-11
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Pharmedium Services, LLC
- NDC code
- 61553-836-11
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0976-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Pharmedium Services, LLC
All 2016 recalls
Class II · Moderate risk
fentaNYL Citrate Injection
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Other labeling / mix-up recalls from 2016
All labeling / mix-up recalls
Class III · Low risk
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick
Labeling: Label Mix Up- Incorrect back label applied to the product.
Class III · Low risk
Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation
Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
Class III · Low risk
Amoxicillin for Oral suspension
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Class III · Low risk
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
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