Drug recall
S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa…
FDA recall event 71618 · Class II · The Apothecary Shoppe LLC
Key facts
| Event ID | 71618 |
|---|---|
| Recall numbers | D-1289-2015, D-1290-2015, D-1291-2015, D-1292-2015, D-1293-2015, D-1294-2015, D-1295-2015, D-1296-2015, D-1297-2015, D-1298-2015, D-1299-2015, D-1300-2015 and 16 more |
| Recalling firm | The Apothecary Shoppe LLC |
| Product type | Drugs |
| Products | S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80, SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34, SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05, SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10 and 23 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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., Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.. |
| Initiation date | Jun 26, 2015 |
| Report date | Aug 12, 2015 |
| Termination date | Feb 17, 2017 |
| City | Tulsa |
| State | OK |
| Country | United States |
| FEI number | 3001576820 |
At a glance
- 10–99 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: