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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-1167-2022

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
1,966 mLs in 12 oz; 2 oz; 16 oz and 6 oz bottles
Official record key
drug-enforcement:D-1167-2022

Official wording

Reason: Subpotent drug

Code information: Lot #: 03312022@29, BUD: 6/10/2022

Distribution pattern: CA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent