The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1673-2012·Announced 2012-09-12

Medtech Recalls Little Remedies For Tummys Laxative Drops for Subpotency

Medtech Products Inc. is recalling Little Remedies For Tummys Stimulant Laxative Drops because the sennosides ingredient is subpotent.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level where the use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

Plain-English summary

Medtech Products Inc. is recalling Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL). The recall involves 12,720 bottles of the product, identified by Lot # 11338 and an expiration date of 04/13.

The FDA has classified this as a Class II recall. The product is being recalled because of sub-potency of the sennosides ingredient, meaning the active ingredient may not be present in the required amount. The product was distributed nationwide.

Consumers who have this product should stop using it and return it to the place of purchase or contact Medtech Products Inc. for further instructions.

The recalled product

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.
Manufacturer
Medtech Products, Inc.
Category
Drug — Laxative
Hazard
Affected units
12,720

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 11338
  • Exp 04/13

Distribution

Distributed nationwide across the United States.

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