Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot: THE190501, Exp 11/2022
Why it was recalled
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.
Recalling firm
- Firm
- Nostrum Laboratories Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1800 N Topping Ave, N/A, Kansas City, Missouri 64120-1228
Distribution
- Quantity
- 4722 bottles
- Distribution pattern
- TN, MO
Timeline
- Recall initiated
- 2020-03-06
- FDA classified
- 2020-03-25
- Posted by FDA
- 2020-04-01
- Terminated
- 2022-04-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1059-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.