Theophylline Extended-Release Tablets recalled over manufacturing violations

Recall date

March 6, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Nostrum Laboratories Inc recalls Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laborato…

Recall number

D-1059-2020

FDA classification

Class II

Brand / firm

Nostrum Laboratories Inc

Sold / distributed

TN, MO

Why it was recalled

CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.