FDA Drug Recalls

Recalls / Class II

Class IID-1673-2012

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.

Affected lot / code info
Lot # 11338, Exp 04/13

Why it was recalled

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

Recalling firm

Firm
Medtech Products, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
90 North Broadway, N/A, Irvington, New York 10533

Distribution

Quantity
12,720 bottles
Distribution pattern
Nationwide

Timeline

Recall initiated
2012-06-20
FDA classified
2012-09-06
Posted by FDA
2012-09-12
Terminated
2017-04-11
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1673-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.