CLASS II Drug recall · Reported 1 Feb 2023 · FDA Enforcement Report
Progesterone-gs Oil- 100mg/ML Vial) Injectable recalled
Pharmacy Innovations is recalling Progesterone-gs Oil- 100mg/ML Vial) 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-0233-2023
- 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
PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Which lots are affected?
t20221116@36
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 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.
Other products in this recall event
58 other products · FDA event 91332This product is part of a recall event; the main page for the event is Glutathione L Reduced 100mg/ML Nebvl) Inhalation recalled.
More recalls from Pharmacy Innovations
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycerin Sterile 99% Vial and Vial, Injectable recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Phosphatidylcholine/deoxycholic Acid Vial) 50mg/50mg/ML 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 |