Drug recall: S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 741
The Apothecary Shoppe LLC (Tulsa, OK) initiated this drug recall on 26 Jun 2015; FDA lists 28 product records under event 71618, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 52% of the 292 drug enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 17 Feb 2017. Initiation: voluntary: firm initiated. The Apothecary Shoppe LLC has 2 enforcement events on this register, with a median of 28 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
The Apothecary Shoppe LLC, Tulsa, OK.
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."
Distribution
"Oklahoma"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1289-2015 | S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40 | 64 mL | Class II | Terminated | 12 Aug 2015 |
| D-1290-2015 | S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80 | 98 mL | Class II | Terminated | 12 Aug 2015 |
| D-1291-2015 | SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34 | 1200.4 mL | Class II | Terminated | 12 Aug 2015 |
| D-1292-2015 | S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19 | 25.3 mL | Class II | Terminated | 12 Aug 2015 |
| D-1293-2015 | SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05 | 23 mL | Class II | Terminated | 12 Aug 2015 |
| D-1294-2015 | SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10 | 32.5 mL | Class II | Terminated | 12 Aug 2015 |
| D-1295-2015 | SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57 | 20 mL | Class II | Terminated | 12 Aug 2015 |
| D-1296-2015 | SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10 | 70 mL | Class II | Terminated | 12 Aug 2015 |
| D-1297-2015 | SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97 | 378 mL | Class II | Terminated | 12 Aug 2015 |
| D-1298-2015 | SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10 | 55 mL | Class II | Terminated | 12 Aug 2015 |
| D-1299-2015 | SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01 | 2.5 mL | Class II | Terminated | 12 Aug 2015 |
| D-1300-2015 | SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43 | 10 mL | Class II | Terminated | 12 Aug 2015 |
| D-1301-2015 | SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01 | 163 mL | Class II | Terminated | 12 Aug 2015 |
| D-1302-2015 | SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2348-22 | 5 mL | Class II | Terminated | 12 Aug 2015 |
| D-1303-2015 | SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48 | 55 mL | Class II | Terminated | 12 Aug 2015 |
| D-1304-2015 | SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70 | 2.5 mL | Class II | Terminated | 12 Aug 2015 |
| D-1305-2015 | SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18 | 555.5 mL | Class II | Terminated | 12 Aug 2015 |
| D-1306-2015 | SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85 | 10 mL | Class II | Terminated | 12 Aug 2015 |
| D-1307-2015 | SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39 | 5 mL | Class II | Terminated | 12 Aug 2015 |
| D-1308-2015 | SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10 | 67.5 mL | Class II | Terminated | 12 Aug 2015 |
| D-1309-2015 | SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47 | 75 mL | Class II | Terminated | 12 Aug 2015 |
| D-1310-2015 | SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36 | 55 mL | Class II | Terminated | 12 Aug 2015 |
| D-1311-2015 | SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17 | 113 mL | Class II | Terminated | 12 Aug 2015 |
| D-1312-2015 | SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94 | 40 mL | Class II | Terminated | 12 Aug 2015 |
| D-1313-2015 | SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | N/A | Class II | Terminated | 12 Aug 2015 |
| D-1314-2015 | SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | 10 mL | Class II | Terminated | 12 Aug 2015 |
| D-1315-2015 | SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | 34 mL | Class II | Terminated | 12 Aug 2015 |
| D-1316-2015 | S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | 750 mL | Class II | Terminated | 12 Aug 2015 |
Context
Other enforcement events for The Apothecary Shoppe LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Sep 2016 | Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding | Drug | Class II | 3 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Oklahoma"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Feb 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.