Drug recall
Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe…
FDA recall event 75212 · Class II · The Apothecary Shoppe LLC
Key facts
| Event ID | 75212 |
|---|---|
| Recall numbers | D-0002-2017, D-0003-2017, D-0004-2017 |
| Recalling firm | The Apothecary Shoppe LLC |
| Product type | Drugs |
| Products | Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK, Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK, Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility; medication was sterilized with a recalled filter |
| Initiation date | Sep 12, 2016 |
| Report date | Oct 12, 2016 |
| Termination date | Jan 25, 2018 |
| City | Tulsa |
| State | OK |
| Country | United States |
| FEI number | 3001576820 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: