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Class II: temporary or reversible health riskTerminated

Nostrum Laboratories Theophylline Recall

Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, M…

Nostrum Laboratories Inc · Kansas City, MO

Risk level
Class II
Reported by FDA
Apr 1, 2020
Recall ID
D-1059-2020
Check your lot numberHow we source this data

Summary

Nostrum Laboratories recalled Theophylline starting Mar 6, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1059-2020 on Apr 1, 2020. Reason: 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. Status: Terminated.

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.

Product description

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.

Lot numbers, UPCs & expiration codes

Lot: THE190501, Exp 11/2022

Where it was sold

TN, MO

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1059-2020
Classification
Class II
Status
Terminated
Recall initiated
Mar 6, 2020
FDA report date
Apr 1, 2020
Quantity
4722 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Nostrum Laboratories Inc

Original FDA data

Every field from FDA enforcement report D-1059-2020, exactly as published.

Show all FDA fields
City
Kansas City
State
MO
Status
Terminated
Country
United States
Event ID
85235
Address
1800 N Topping Ave
Code information
Lot: THE190501, Exp 11/2022
Postal code
64120-1228
Report date
Apr 1, 2020
Product type
Drugs
Recall number
D-1059-2020
Classification
Class II
Recalling firm
Nostrum Laboratories Inc
Product quantity
4722 bottles
Termination date
Apr 1, 2022
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
TN, MO
Recall initiation date
Mar 6, 2020
Initial firm notification
E-Mail
Center classification date
Mar 25, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1059-2020, published Apr 1, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

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