The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1059-2020·Announced 2020-04-01

Nostrum Recalls Theophylline Tablets Due to Incorrect Lot and Expiration Dates

Nostrum Laboratories is recalling Theophylline Extended-Release Tablets because poor manufacturing practices resulted in incorrect lot and expiration date labeling.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to labeling errors (incorrect lot and expiration dates) resulting from poor manufacturing practices, which fits the rubric for minor labeling errors or low-risk contamination without reported illness.

Plain-English summary

Nostrum Laboratories, Inc. is recalling Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottles. The recall involves 4,722 bottles of the prescription medication, identified by Lot THE190501 and an expiration date of 11/2022. The product was distributed in Tennessee and Missouri.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Poor manufacturing practices resulted in the product being incorrectly labeled with the wrong lot and expiration date. This labeling error is classified as an FDA Class II recall.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication. The recalled product is identified by NDC 29033-001-01.

The recalled product

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.
Manufacturer
Nostrum Laboratories Inc
Category
Drug — Prescription Medication
Hazard
Affected units
4,722

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: THE190501
  • Exp 11/2022

Distribution

Distributed in 2 states:

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