Sun Pharmaceutical Industries Inc. and Ohm Laboratories are recalling 201,102 bottles of various medications, including Cinacalcet, Febuxostat, Lurasidone, Mesalamine, Niacin, Zolpidem, and Fexofenadine. The recall was issued because microbial contamination was found in stagnant water in the ducts of manufacturing equipment, violating Current Good Manufacturing Practice (CGMP). The affected medications include a variety of prescription and over-the-counter products distributed in multiple strengths and sizes across the United States.
The presence of stagnant water in manufacturing equipment creates a risk for the growth of bacteria and other microorganisms. If these contaminants enter the drug products during production, they could cause infections or other adverse health reactions, particularly in patients with weakened immune systems.
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Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India.
Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA.
Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA.
Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA.
Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA.
Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA.
Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA.
Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA.
Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA.
Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA.
Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901 and CVS Pharmacy, Inc., Woonsocket, RI 02895. Made in India.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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