D-1059-2020 Class II Terminated
FDA drug recall D-1059-2020 was initiated by Nostrum Laboratories Inc on Mar 6, 2020 and is designated Class II. 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. The recall status is terminated (terminated Apr 1, 2022). Affected quantity: 4722 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 1, 2020
- Initiation Date
- Mar 6, 2020
- Termination Date
- Apr 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4722 bottles
Product description
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.
Distribution pattern
TN, MO
Code information
Lot: THE190501, Exp 11/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1059-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026