FDA-Drug2020-04-01Class II
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.
Nostrum Laboratories Inc
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.
Sold states
TN, MO
Affected count
4722 bottles
Manufactured in
1800 N Topping Ave, N/A, Kansas City, MO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1059-2020Don't want to check this manually?
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