CLASS II Drug recall · Reported 31 May 2017 · FDA Enforcement Report
Add Heparin PF Only TO TPN all strengths recalled by Advanced Pharma
Advanced Pharma is recalling Add Heparin PF Only TO TPN all strengths, all dosage forms and all packaging, distributed nationwide in the US. The recall was initiated on 22 Feb 2017 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-0807-2017
- FDA event ID
- 76561
- Recalling firm
- Advanced Pharma, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Feb 2017
- FDA classified
- 23 May 2017
- Reported
- 31 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Blood Thinners
Timeline
| 22 Feb 2017 | Recall initiated by company | |
| 23 May 2017 | Classified by FDA | +90 days |
| 31 May 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Add Heparin PF Only TO TPN all strengths, all dosage forms and all packaging recalled?
Yes. Advanced Pharma recalled Add Heparin PF Only TO TPN all strengths, all dosage forms and all packaging on 22 Feb 2017. The recall is Class II and its status is Terminated. Recall number D-0807-2017.
Why was it recalled?
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Which lots are affected?
all lots
Where was it sold?
U.S. Nationwide
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | HYDROmorphone 20 mg/ Injectable Solution recalled by Advanced Pharma | Advanced Pharma | Sterility | Nationwide |
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| Drug | CLASS II | HYDROmorphone HCl 1 mg in 9% Sodium Chloride recalled by Advanced Pharma | Advanced Pharma | Sterility | Nationwide |
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