CLASS II Drug recall · Reported 5 Jul 2017 · FDA Enforcement Report
Progesterone Injection in Olive Oil With Benzyl Alcohol recalled
Apothecary By Design is recalling Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL Multi-Dose Vial, distributed nationwide in the US. The recall was initiated on 5 Jun 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-0924-2017
- FDA event ID
- 77615
- Recalling firm
- Apothecary By Design, Portland, ME
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2017
- FDA classified
- 28 Jun 2017
- Reported
- 5 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Jun 2017 | Recall initiated by company | |
| 28 Jun 2017 | Classified by FDA | +23 days |
| 5 Jul 2017 | Published in enforcement report | +7 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 Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Which lots are affected?
Lot #: 04192017@1, Exp 09/30/2017
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 Progesterone recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Progesterone Injection USP, 500mg per (50mg/mL) Multiple Dose Vial recalledProgesterone | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Progesterone Injection, USP, 500 mg per (50mg/mL) Multiple-Dose Vial recalledProgesterone | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Progesterone 200 mg, Compounded, Rx recalled by Coast Quality Pharmacy | Coast Quality Pharmacy | Foreign Material | Nationwide |
| Drug | CLASS II | Progesterone 100mg/ML Inj # Ethyl Oleate Injectable recalled | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Progesterone 100mg/ML Mdv Oil Injection recalled | First Royal Care Co. LLC | Sterility | 7 states |