FDAFDA · Food and drugs·Recall number 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.
Published April 1, 2020 · Recall initiated: March 6, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Nostrum Laboratories Inc
- Distributor
- TN, MO
- Lot
- Lot: THE190501, Exp 11/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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