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The Apothecary Shoppe LLC

Complete recall history across all FDA and CPSC categories — 31 total recalls

The Apothecary Shoppe LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (31)

FDA drug safety enforcement actions by The Apothecary Shoppe LLC

Date Product Reason Class
Sep 12, 2016 Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, ... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II
Sep 12, 2016 Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL)... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II
Sep 12, 2016 Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II
Jun 26, 2015 SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compound... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shop... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Com... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compoun... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe,... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Com... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Comp... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compo... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shopp... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compoun... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Com... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II
Jun 26, 2015 SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apo... Lack of Assurance of Sterility: Due to lack of documentation of proper enviro... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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