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FDAMarch 6, 2020drug

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 recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

nostrum laboratoriesnostrum

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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