CLASS II Drug recall · Reported 1 Feb 2023 · FDA Enforcement Report
Phosphatidylcholine/deoxycholic Acid Vial) 50mg/50mg/ML recalled
Pharmacy Innovations is recalling Phosphatidylcholine/deoxycholic Acid Vial) 50mg/50mg/ML (5%/5%) Injectable, distributed nationwide in the US. The recall was initiated on 22 Dec 2022 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-0230-2023
- FDA event ID
- 91332
- Recalling firm
- Pharmacy Innovations, Erie, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Dec 2022
- FDA classified
- 26 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Dec 2022 | Recall initiated by company | |
| 26 Jan 2023 | Classified by FDA | +35 days |
| 1 Feb 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Phosphatidylcholine/deoxycholic Acid Vial) 50mg/50mg/ML (5%/5%) Injectable recalled?
Yes. Pharmacy Innovations recalled Phosphatidylcholine/deoxycholic Acid Vial) 50mg/50mg/ML (5%/5%) Injectable on 22 Dec 2022. The recall is Class II and its status is Terminated. Recall number D-0230-2023.
Why was it recalled?
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Which lots are affected?
t20221025@32
Where was it sold?
Nationwide in the USA
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.
More recalls from Pharmacy Innovations
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|---|---|---|---|---|---|
| Drug | CLASS II | Glycerin Sterile 99% Vial and Vial, Injectable recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Dexamethasone 16mg/ML Vial) Injectable recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Lidocaine-pf- 5% Vial) Injectable recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Ethyl Alcohol 95% vial) Injectable recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Chlorpheniramine/Hyoscyamine 10MG/0.25MG/ML Injectable recalled | Pharmacy Innovations | Sterility | Nationwide |