Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Theophylline (Anhydrous) Extended-Release Tablets Recalled by Nostrum Laboratories Inc Due to CGMP Deviations: poor manufacturing practices resulted in Labeling:...

Date: March 6, 2020
Company: Nostrum Laboratories Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nostrum Laboratories Inc directly.

Affected Products

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.

Quantity: 4722 bottles

Why Was This 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.

Where Was This Sold?

This product was distributed to 2 states: MO, TN

Affected (2 states)Not affected

About Nostrum Laboratories Inc

Nostrum Laboratories Inc has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report