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Recall Observatory FDA recall evidence

Drug product

Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.

D-1673-2012

June 20, 2012

Class II

Product summary

Firm
Medtech Products, Inc.
Event
Event 62402
Status
Terminated
Classification
Class II
Quantity
12,720 bottles
Official record key
drug-enforcement:D-1673-2012

Official wording

Reason: Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.

Code information: Lot # 11338, Exp 04/13

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent