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Recall Observatory FDA recall evidence

Drug product

Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx Only, Distributed by arbor Atlanta, GA, NDC 24338-200-12

D-1625-2020

September 16, 2020

Class III

Product summary

Firm
Arbor Pharmaceuticals Inc.
Event
Event 86392
Status
Terminated
Classification
Class III
Quantity
1846 cartons
Official record key
drug-enforcement:D-1625-2020

Official wording

Reason: Subpotent Drug

Code information: Lot #: 356884 Exp. 11/30/2021

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent