Theophylline — Class II drug recall D-1059-2020
Terminated recall by Nostrum Laboratories Inc, reported 2020-04-01, distributed in MO, TN. CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date,
| Recall number | D-1059-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nostrum Laboratories Inc, Kansas City, MO, United States |
| Recall initiated | 2020-03-06 |
| Classified | 2020-03-25 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2022-04-01 |
| Distributed | MO, TN |
| Quantity | 4,722 bottles |
| Reason classes | labeling, cgmp |
| NDC | 29033-0001-01 |
| Lot numbers | THE190501 |
| Expiration dates | 2022-11 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1059-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.