FDA recall D-1059-2020

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.

Reason for recall

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.

Distribution

TN, MO

Key facts

Status

Terminated

Initiation date

2020-03-06

Report date

2020-04-01

Termination date

2022-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kansas City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1059-2020