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Recall Observatory FDA recall evidence

Drug product

Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90

D-1145-2015

May 06, 2015

Class III

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 71375
Status
Terminated
Classification
Class III
Quantity
Unavailable
Official record key
drug-enforcement:D-1145-2015

Official wording

Reason: Subpotent drug

Code information: Lot # C309280

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent