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Recall Observatory FDA recall evidence

Drug product

Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 33342-054-07

D-0140-2020

September 23, 2019

Class II

Product summary

Firm
Macleods Pharma Usa Inc
Event
Event 83960
Status
Terminated
Classification
Class II
Quantity
31,968 bottles
Official record key
drug-enforcement:D-0140-2020

Official wording

Reason: Superpotent

Code information: Lot # BPF901A, exp. date 12/2021

Distribution pattern: Product was shipped to 8 distributors who may have further distributed the product.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent