CLASS II Drug recall · Reported 12 Oct 2016 · FDA Enforcement Report
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL recalled
The Apothecary Shoppe is recalling Phenotolamine 0.4mg/Prostaglandin 20mcg/mL, distributed in Oklahoma. The recall was initiated on 12 Sep 2016 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-0003-2017
- FDA event ID
- 75212
- Recalling firm
- The Apothecary Shoppe, Tulsa, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2016
- FDA classified
- 4 Oct 2016
- Reported
- 12 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Sep 2016 | Recall initiated by company | |
| 4 Oct 2016 | Classified by FDA | +22 days |
| 12 Oct 2016 | 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
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
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
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Where it was distributed
Oklahoma
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Which lots are affected?
05162016@18 BUD 09/13/2016; 07052016@9 BUD 11/02/2016; 08032016@13 BUD 12/01/2016
Where was it sold?
Oklahoma
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
2 other products · FDA event 75212This product is part of a recall event; the main page for the event is Methylcobalamin 5000 mcg/mL Injection recalled by The Apothecary Shoppe.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Methylcobalamin 5000 mcg/mL Injection recalled by The Apothecary Shoppe | The Apothecary Shoppe | Sterility | OK | |
| CLASS II | Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg recalled | The Apothecary Shoppe | Sterility | OK |