US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 6, 2020 (6 years ago)

Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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.

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.

Recalling firm
Nostrum Laboratories Inc
NDC code
29033-001-01
Origin
MO, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1059-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Anhydrous recalls

See all