Reported Mar 2, 2022 · Terminated

Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530…

Dr. Reddy's Laboratories, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623

Is this the product you have?

  • Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd
  • ByDr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62
Lot codes and dates

8 of 8 products

Products covered by this recall
#Product as published
1H200101, H200102, H200099, H200100 & H200106, Exp 8/1/2023
2H210015, H210014 & H210013, Exp 11/1/2023
3H210086, Exp 12/1/2023
4H210130, Exp 1/1/2024
5H210171, H210172, H210173, H210174, Exp 2/1/2024
6H210196 & H210197, Exp 3/1/2024
7H210283 & H210282, Exp 4/1/2024
8H210382, H210381, H210419 & H210420, Exp 7/1/2024, H210445, Exp 8/1/2024.
Amount recalled
68061 vials

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

Failed stability specifications

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 13, 2022 · Data as of Sep 19, 7:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.