Food, drugs, devices › Nostrum Laboratories Inc
Drug recall: Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laborator
Nostrum Laboratories Inc (Kansas City, MO) initiated this drug recall on 6 Mar 2020; FDA lists 1 product record under event 85235, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 1 Apr 2022. Initiation: voluntary: firm initiated. Nostrum Laboratories Inc has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Nostrum Laboratories Inc, Kansas City, MO.
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."
Distribution
"TN, MO"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1059-2020 | 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. | 4722 bottles | Class II | Terminated | 1 Apr 2020 |
Context
Other enforcement events for Nostrum Laboratories Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Jul 2025 | Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033- | Drug | Class II | 1 |
| 25 Jan 2021 | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum | Drug | Class II | 1 |
| 4 Jan 2021 | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum | Drug | Class II | 1 |
| 23 Oct 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Labor | Drug | Class II | 2 |
| 13 Feb 2018 | Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas Ci | Drug | Class III | 1 |
| 23 May 2016 | Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle | Drug | Class II | 1 |
All 7 events for Nostrum Laboratories Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "TN, MO"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Apr 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.