Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Virtus Pharmaceuticals, Llc

NDC code

76439-0309-10

Origin

FL, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-1044-2016

Other Hyoscyamine recalls

See all

Class II · Moderate risk Terminated May 25, 2023

Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx…

Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…

Viatris Inc NDC 0037-9001-05 D-0866-2023

Class II · Moderate risk Terminated Dec 22, 2022

Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Pharmacy Innovations D-0186-2023

Class II · Moderate risk Terminated Jul 24, 2020

VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg…

Reason cGMP deviations

Vilvet Pharmaceuticals Inc. NDC 71186-000-24 D-1488-2020

Class II · Moderate risk Terminated Jul 24, 2020

VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg…

Reason cGMP deviations

Vilvet Pharmaceuticals Inc. NDC 71186-002-35 D-1487-2020

Class II · Moderate risk Terminated May 21, 2019

Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.

Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Torrent Pharma Inc D-1360-2019