Senna Laxative (sennosides) tablets…

Date

Feb. 21, 2018

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Terminated

Filed by

Magno Humphries Laboratories, Inc

Product

Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC Code 3 07610 22020 1.

Reason

Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.

Distribution pattern

Nationwide in the USA

Quantity

2,400 bottles

Codes and lots

Lot # 352300, Exp 01/19

Recall started

Jan. 17, 2018

Recall number

D-0342-2018

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0342-2018. The agency record governs; check it and the company before acting.