Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Supply Disruption — Nostrum Laboratories Inc (Mode
Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Supply Disruption — Nostrum Laboratories Inc (Mode is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx; Manufacturer: Nostru
| Drug name | Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx |
|---|---|
| Manufacturer | Nostrum Laboratories Inc |
| Recall/Disruption reason | CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product in |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-1059-2020 |
| Initiation date | 20200306 |
| Quantity affected | 4722 bottles |
| Dosage form | Drugs |
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