The Recall Desk
ModerateFDA (Drugs)·D-0525-2022·Announced 2022-02-16

Zee Cold Tabs Recalled for CGMP Manufacturing Deviations

ULTRAtab Laboratories is recalling Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg) in bulk form due to Current Good Manufacturing Practice (CGMP) deviations.

What this means for you

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: This is an FDA Class II recall initiated voluntarily by the manufacturer for CGMP deviations. The source text does not report any illnesses, injuries, or hospitalizations related to the product, and the hazard is manufacturing-related rather than a specific safety defect. Class II recalls without reported harm are typically scored as 2 (Moderate).

Plain-English summary

ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling approximately 1,798,048 tablets of Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg) in bulk container form, NDC 62959-111-xx, due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

The recalled product code is C111L (Bulk Lot: 18L028). The bulk product was distributed to three distributors, who may have further distributed finished product to end users.

Consumers who have purchased this product should stop using it. Patients with questions about this recall or their health should contact their healthcare provider. Healthcare providers and pharmacists who have stock of this product should check their inventory and quarantine affected batches.

The recalled product

Product
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Drug — Cold and Cough Preparation
Hazard
  • cgmp-deviation
  • manufacturing-non-compliance

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 (1)

  • Product Codes: C111L Bulk Lot: 18L028

Distribution

Distribution scope not specified by the agency.

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