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Recall Observatory FDA recall evidence

Drug product

Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704

D-1168-2022

April 15, 2022

Class I

Product summary

Firm
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
Event
Event 90289
Status
Terminated
Classification
Class I
Quantity
950 mLs in 1x8 oz and 2x16 oz bottles.
Official record key
drug-enforcement:D-1168-2022

Official wording

Reason: Subpotent drug

Code information: Lot #: 04272022@35, BUD: 7/7/2022.

Distribution pattern: CA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent