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Drug recall · FDA · Published June 26, 2015

The Apothecary Shoppe LLC recalls SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy,

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

🇺🇸 FDA recall #D-1312-2015DrugThe Apothecary Shoppe LLC ›
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Recalling firmThe Apothecary Shoppe LLC6136 E 51st St, N/A · Tulsa, OK 74135-7704
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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Source Page by GovInfoNow · govinfonow.com/recall/44116-the-apothecary-shoppe-llc-recalls-so-acetylcysteine-10-sterile-ophthalmic · Recall date June 26, 2015 · FDA enforcement record: FDA #D-1312-2015

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“The Apothecary Shoppe LLC recalls SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy,.” GovInfoNow, recall dated June 26, 2015. https://govinfonow.com/recall/44116-the-apothecary-shoppe-llc-recalls-so-acetylcysteine-10-sterile-ophthalmic. Based on FDA recall #D-1312-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1312-2015%22&limit=1).

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  • Brand
    The Apothecary Shoppe LLC
  • Category
    Drug
FDA recall event · 28 products

All 28 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Oklahoma
Recall numberProduct, codes & lotsQuantity
D-1289-2015S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40; Lot #s: 03132015@28, BUD 9/9/2015; 04082015@46, BUD 10/5/2015; 04222015@5, BUD 10/19/201564 mL
D-1290-2015S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80; Lot #: 04302015@66, BUD 06/29/201598 mL
D-1291-2015SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34; Lot #: 04142015@5, BUD 8/12/2015; 04032015@23, BUD 7/2/2015; 04242015@28, BUD 8/22/20151200.4 mL
D-1292-2015S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19; Lot #: 04232015@28, BUD 10/20/201525.3 mL
D-1293-2015SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05; Lot #: 04202015@33, BUD 8/18/2015; 04272015@18, BUD 8/25/201523 mL
D-1294-2015SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10; Lot #: 04152015@6, BUD 10/12/2015; 03102015@41, BUD 07/08/201532.5 mL
D-1295-2015SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57; Lot #: 04232015@22, BUD 10/20/201520 mL
D-1296-2015SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10; Lot #s: 03102015@30, BUD 7/8/2015; 04162015@30, BUD 10/13/201570 mL
D-1297-2015SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97; Lot #s: 04282015@9, BUD 10/25/2015; 04172015@15, BUD 10/14/2015; 04022015@10, BUD 9/1/2015378 mL
D-1298-2015SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10; Lot #: 04162015@30, BUD 10/13/201555 mL
D-1299-2015SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01; Lot #: 04082015@37, BUD 10/05/20152.5 mL
D-1300-2015SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43; Lot #: 03172015@39, BUD 07/15/201510 mL
D-1301-2015SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01; Lot #s: 04172015@33, BUD 10/14/2015; 04292015@10, BUD 10/26/2015163 mL
D-1302-2015SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2348-22; Lot #: 04162015@36, BUD 10/13/20155 mL
D-1303-2015SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48; Lot #: 04202015@34, BUD 10/17/201555 mL
D-1304-2015SIU-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; Lot #: 03192015@27, BUD 07/13/20152.5 mL
D-1305-2015SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18; Lot #s: 04062015@30, BUD: 09/01/2015; 04172015@20, BUD: 10/14/2015555.5 mL
D-1306-2015SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85; Lot #: 05202015@14, BUD 11/16/201510 mL
D-1307-2015SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39; Lot #: 05052015@39, BUD 11/1/20155 mL
D-1308-2015SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10; Lot #s: 04162015@41, BUD: 10/13/2015; 03122015@42, BUD: 7/10/201567.5 mL
D-1309-2015SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47; Lot #s: 04082015@45, BUD 9/1/2015; 04162015@28, BUD 10/13/2015; 03182015@9, BUD 7/16/201575 mL
D-1310-2015SIU-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; Lot #s: 05052015@11, 05052015@28, BUD 11/1/2015; 03102015@38, BUD 7/8/201555 mL
D-1311-2015SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17; Lot #s: 04102015@38, BUD: 9/1/2015; 03132015@37, BUD: 7/11/2015; 04172015@28, BUD: 10/14/2015113 mL
D-1312-2015SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94; Lot #: 05062015@28, BUD 07/05/201540 mL
D-1313-2015SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135; Lot #: 05042015@33, BUD 10/31/2015; 03102015@45, 03112015@14, 03192015@42, BUD 09/01/2015N/A
D-1314-2015SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135; Lot #: 03102015@42, BUD 09/06/201510 mL
D-1315-2015SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135; Lot #: 04222015@20, BUD 08/30/201534 mL
D-1316-2015S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135; Lot #: 05012015@4, BUD 10/28/2015750 mL
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Contact The Apothecary Shoppe LLC

We’ve drafted a message you can send The Apothecary Shoppe LLC to request your refund or repair — edit it as you like.

Subject: Recall D-1312-2015 — The Apothecary Shoppe LLC The Apothecary Shoppe LLC recalls SO-Acetylcysteine 10% Sterile Ophthalmi

Hello,

I own a The Apothecary Shoppe LLC recalls SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, that is covered by recall D-1312-2015 from The Apothecary Shoppe LLC.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1312-2015 (June 26, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1312-2015 to see it in context.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA