CLASS II Drug recall · Reported 30 Jan 2019 · FDA Enforcement Report
Heperain 50 mg/ (1mg/mL) Injectable Solution recalled by Advanced Pharma
Advanced Pharma is recalling Heperain 50 mg/ (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS, distributed in Texas, Washington. The recall was initiated on 15 Jan 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0430-2019
- FDA event ID
- 81941
- Recalling firm
- Advanced Pharma, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jan 2019
- FDA classified
- 8 Feb 2019
- Reported
- 30 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Blood Thinners
Timeline
| 15 Jan 2019 | Recall initiated by company | |
| 30 Jan 2019 | Published in enforcement report | +15 days |
| 8 Feb 2019 | Classified by FDA | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)
Product as listed by the FDA
HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe, Avella of Houston an FDA Registered 503B Outsourcing Facility 9265 Kirby Dr. Houston, TX 77054 (877) 794-0404 ---- NDC: 42852-725-65
Where it was distributed
TX, WA
Questions about this recall
Why was it recalled?
Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)
Which lots are affected?
Lot: 12/19/18 0242 72565S BUD: 3/31/19
Where was it sold?
TX, WA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Advanced Pharma
All 99| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HYDROmorphone 20 mg/ Injectable Solution recalled by Advanced Pharma | Advanced Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection Solution 5 mg recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Heparin in 0.45% Sodium Chloride, QS, Injectable Solution recalled | Advanced Pharma | Sterility | Nationwide |