CLASS II Drug recall · Reported 1 Apr 2020 · FDA Enforcement Report
Theophylline (Anhydrous) Extended-Release Tablets, 400 mg recalled
Nostrum Laboratories is recalling Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, distributed in Missouri, Tennessee. The recall was initiated on 6 Mar 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1059-2020
- FDA event ID
- 85235
- Recalling firm
- Nostrum Laboratories, Kansas City, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Mar 2020
- FDA classified
- 25 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
Timeline
| 6 Mar 2020 | Recall initiated by company | |
| 25 Mar 2020 | Classified by FDA | +19 days |
| 1 Apr 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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 as listed by the FDA
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.
Where it was distributed
TN, MO
Questions about this recall
Why was it 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.
Which lots are affected?
Lot: THE190501, Exp 11/2022
Where was it sold?
TN, MO
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nostrum Laboratories
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sucralfate Tablets recalled by Nostrum Laboratories | Nostrum Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |