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Drug recall · FDA · Published August 13, 2015

Dr. Reddy's Laboratories, Inc. recalls Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr.

Subpotent Drug: Subpotent atorvastatin.

🇺🇸 FDA recall #D-1379-2015DrugDr. 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/43853-dr-reddy-s-laboratories-inc-recalls-amlodipine-besylate-and-atorvastatin · Recall date August 13, 2015 · FDA enforcement record: FDA #D-1379-2015

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“Dr. Reddy's Laboratories, Inc. recalls Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr..” GovInfoNow, recall dated August 13, 2015. https://govinfonow.com/recall/43853-dr-reddy-s-laboratories-inc-recalls-amlodipine-besylate-and-atorvastatin. Based on FDA recall #D-1379-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1379-2015%22&limit=1).

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  • Brand
    Dr. Reddy's Laboratories, Inc.
  • Category
    Drug
FDA recall event · 7 products

All 7 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 III
  • Status
    Terminated
  • Distribution
    U.S. Nationwide
  • NDC
    43598-323-30, 43598-323-60, 43598-323-90, 43598-323-05, 43598-320-30, 43598-320-60, 43598-320-90, 43598-320-05, 43598-317-30, 43598-317-60, 43598-317-90, 43598-317-05, 43598-322-30, 43598-322-60, 43598-322-90, 43598-322-05, 43598-319-30, 43598-319-60, 43598-319-90, 43598-319-05, 43598-316-30, 43598-316-60, 43598-316-90, 43598-316-05, 43598-314-30, 43598-314-60, 43598-314-90, 43598-314-05, 43598-321-30, 43598-321-60, 43598-321-90, 43598-321-05, 43598-318-30, 43598-318-60, 43598-318-90, 43598-318-05, 43598-315-30, 43598-315-60, 43598-315-90, 43598-315-05, 43598-313-30, 43598-313-60, 43598-313-90, 43598-313-05
Recall numberProduct, codes & lotsQuantity
D-1373-2015Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-323-30.; Lot #: C403575, Expiry: 10/20151,056 Bottles
D-1374-2015Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-320-30.; Lot #: C403574, Expiry: 10/2015576 Bottles
D-1375-2015Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-317-30.; Lot #: C402341, Expiry: 08/2015984 Bottles
D-1376-2015Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.; a) Lot #: C403577, Expiry: 10/2015; b) Lot #: C403577, Expiry: 10/2015.a) 14,640 and b) 624 Bottles
D-1377-2015Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India; a) Lot #: C404592, Expiry: 11/2015. b) Lot #: C404592, Expiry: 11/2015a) 16,080 and b) 480 Bottles
D-1378-2015Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.; a) Lot #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016a) 16,848 and b) 216 Bottles
D-1379-2015Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-313-30.; Lot #: C404595, Expiry: 11/20153840 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-1379-2015 — Dr. Reddy's Laboratories, Inc. Dr. Reddy's Laboratories, Inc. recalls Amlodipine besylate and Atorv

Hello,

I own a Dr. Reddy's Laboratories, Inc. recalls Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. that is covered by recall D-1379-2015 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-1379-2015 (August 13, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1379-2015 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