CLASS II Drug recall · Reported 12 Aug 2015 · FDA Enforcement Report

SIU-Papav/Phent 24/1 mg/mL Inj recalled by The Apothecary Shoppe

The Apothecary Shoppe is recalling SIU-Papav/Phent 24/1 mg/mL Inj, distributed in Oklahoma. The recall was initiated on 26 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 04232015@22, BUD 10/20/2015

Quantity recalled20 mL

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-1295-2015
FDA event ID: 71618
Recalling firm: The Apothecary Shoppe, Tulsa, OK
Classification: Class II
Status: Terminated
Recall initiated: 26 Jun 2015
FDA classified: 6 Aug 2015
Reported: 12 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

26 Jun 2015	Recall initiated by company
6 Aug 2015	Classified by FDA	+41 days
12 Aug 2015	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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..

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

SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57

Where it was distributed

Oklahoma

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..

Which lots are affected?

Lot #: 04232015@22, BUD 10/20/2015

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

27 other products · FDA event 71618

This product is part of a recall event; the main page for the event is SO-Acetylcysteine 10% Sterile Ophthalmic Solution recalled.

Reported	Class	Recall	Company	Reason	Where
12 Aug 2015	CLASS II	SO-Acetylcysteine 10% Sterile Ophthalmic Solution recalled	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Tri-Mix 18/1/20 Injection recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	S-Chorionic Gonad HCG 1000 U/mL Injection recalled	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Papav/Phent 30/1 mg Inj recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	S-Methylcobalamin 5000 mcg/mL Inj recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Tri-Mix 30/2/20 Inj recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Tri-Mix 30/1/10 Injection recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Papav/Phentol 30/.5 mg/mL Injection recalled	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Papav/Phentol 30/1 mg/mL Injection recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIH-Testosterone Cyp recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Tri-Mix 20/1 mg/10 mcg/mL recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Tri-Mix 6/0.33/3.33 Injection Solution recalled	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	S-Methylcobalamin 1000 mcg/mL (PF) Injection recalled	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Tri-Mix 30/1/20 Injectable recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Prostaglandin E1 20 mcg/mL Injection recalled	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Phentolamine 5 mg/mL in Normal Saline recalled	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Phent .8/PGE1 20 mcg/mL Inj recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Prostaglandin E1 500 mcg/mL Injection recalled	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIH-Hydroxyprogesterone Caproate recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	S-methylcobalamin 25 mg/mL (PF) Injection recalled	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIH-Testosterone Cyp recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Tri-Mix 18/1/10 Injection recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Tri-Mix 24/1/20 Injection recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Tri-Mix 17/0.6/5.7 Injectable recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Phent .4 mg/PGE1 20 mcg/mL Injection recalled	The Apothecary Shoppe	Sterility	OK
12 Aug 2015	CLASS II	SIU-Papaverine 30 mg/mL Inj recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK

More recalls from The Apothecary Shoppe

All 31

Reported	Class	Recall	Company	Reason	Where
12 Oct 2016Drug	CLASS II	Phenotolamine 0.4mg/Prostaglandin 20mcg/mL recalled	The Apothecary Shoppe	Sterility	OK
12 Oct 2016Drug	CLASS II	Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg recalled	The Apothecary Shoppe	Sterility	OK
12 Oct 2016Drug	CLASS II	Methylcobalamin 5000 mcg/mL Injection recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015Drug	CLASS II	SIU-Papaverine 30 mg/mL Inj recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015Drug	CLASS II	SIU-Phent .4 mg/PGE1 20 mcg/mL Injection recalled	The Apothecary Shoppe	Sterility	OK

Other Siu-papav recalls

All 4

Reported	Class	Recall	Company	Reason	Where
12 Aug 2015Drug	CLASS II	SIU-Papav/Phentol 30/1 mg/mL Injection recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK
12 Aug 2015Drug	CLASS II	SIU-Papav/Phentol 30/.5 mg/mL Injection recalled	The Apothecary Shoppe	Sterility	OK
12 Aug 2015Drug	CLASS II	SIU-Papav/Phent 30/1 mg Inj recalled by The Apothecary Shoppe	The Apothecary Shoppe	Sterility	OK