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 in 0.45% Sodium Chloride
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Stability Data Does Not Support Expiry
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163
Affected NDC
52533-0148-16
Compare with the code on your package — it is the most precise check available.
Drug: Heparin
- Recalling firm
- Cantrell Drug Company
- NDC code
- 52533-148-16
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1160-2016 · 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 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 Cantrell Drug Company
All 2015 recalls
Class II · Moderate risk
Rocuronium Bromide Injection Solution 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Neostigmine Methylsulfate Injection Solution 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Adenosine in 0.9% Sodium Chloride 30mL
Lack of Sterility Assurance.
Class II · Moderate risk
Sodium Bicarbonate 8.4% Injection Solution 50 mL
Lack of Sterility Assurance.
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