Class I · High risk
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection)
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
HEPARIN Sodium Inj. USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.
Drug: Heparin
- Recalling firm
- Pharmedium Services, LLC
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0049-2017 · 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 Heparin recalls
See all
Class II · Moderate risk
heparin added to 0.9% sodium chloride
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Other recalls by Pharmedium Services, LLC
All 2015 recalls
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.
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.
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