Drug 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.
D-1059-2020
Product summary
- Event
- Event 85235
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4722 bottles
- Official record key
drug-enforcement:D-1059-2020
Official wording
Reason: 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.
Code information: Lot: THE190501, Exp 11/2022
Distribution pattern: TN, MO
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing
-
Manufacturing or process control
CGMP Deviations