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Drug recall · FDA · Published December 28, 2016

Dr. Reddy's Laboratories, Inc. recalls Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090

Failed Dissolution Specifications; 18 month stability time point

🇺🇸 FDA recall #D-0451-2017DrugDr. Reddy's Laboratories, Inc. ›
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Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E, N/A · Princeton, NJ 08540-6623
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/42101-dr-reddy-s-laboratories-inc-recalls-flucanozole-tablets-usp-150 · Recall date December 28, 2016 · FDA enforcement record: FDA #D-0451-2017

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“Dr. Reddy's Laboratories, Inc. recalls Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090.” GovInfoNow, recall dated December 28, 2016. https://govinfonow.com/recall/42101-dr-reddy-s-laboratories-inc-recalls-flucanozole-tablets-usp-150. Based on FDA recall #D-0451-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0451-2017%22&limit=1).

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  • Brand
    Dr. Reddy's Laboratories, Inc.
  • Category
    Drug
FDA recall event · 4 products

All 4 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
    Nationwide
  • NDC
    55111-143-30, 55111-143-01, 55111-143-05, 55111-143-79, 55111-143-78, 55111-144-30, 55111-144-01, 55111-144-05, 55111-144-79, 55111-144-78, 55111-145-71, 55111-145-12, 55111-146-30, 55111-146-01, 55111-146-05, 55111-146-79, 55111-146-78
Recall numberProduct, codes & lotsQuantity
D-0449-2017Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India; a) 30 count C500221, exp 12/2016, C502342, exp 03/2017 b) 100 count C500221, exp 12/2016, C502342, exp 03/2017a) 2472 bottles, b) 780 bottles
D-0450-2017Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India; a) 30 count C500224, exp 12/2016, C500846, exp 01/2017 b) 100 count C500224, exp 12/2016, exp 12/2016, C501608, exp 02/2017 and C503655, exp 04/2017a) 42,984 and b) 7,764 bottles
D-0451-2017Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12; C500222, C500515, and C500517, exp 12/2016, C502343, exp 03/201759,440 blister cards
D-0452-2017Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India; a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C500226, exp 12/2016, C500848, C500850, exp 01/2017, C503649 and C503653, exp 04/2017a) 38,832 and b) 5,064 bottles
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Contact Dr. Reddy's Laboratories, Inc.

We’ve drafted a message you can send Dr. Reddy's Laboratories, Inc. to request your refund or repair — edit it as you like.

Subject: Recall D-0451-2017 — Dr. Reddy's Laboratories, Inc. Dr. Reddy's Laboratories, Inc. recalls Flucanozole Tablets, USP, 150

Hello,

I own a Dr. Reddy's Laboratories, Inc. recalls Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 that is covered by recall D-0451-2017 from Dr. Reddy's Laboratories, Inc..

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-0451-2017 (December 28, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0451-2017 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