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

Recalled April 1, 2020 · FDA recall D-1059-2020 · Nostrum Laboratories

Hazard

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. · FDA Class II

Units

4722 bottles

Sold at

TN, MO

Description

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.

Product

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.

Manufacturer(s)

Nostrum Laboratories Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →