The Recall Desk
ModerateFDA (Drugs)·D-0523-2022·Announced 2022-02-16

3-Component Cold Tabs Recalled for CGMP Deviations

ULTRAtab Laboratories, Inc. is voluntarily recalling 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) in bulk container 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: The FDA classified this as Class II, and the recall is based on CGMP manufacturing deviations without reported illnesses or injuries. This is a precautionary recall initiated by the firm itself, which aligns with the Moderate severity criteria for manufacturing/labeling issues without reported harm.

Plain-English summary

ULTRAtab Laboratories, Inc., located in Highland, NY, is voluntarily recalling 3-Component Cold Tabs in bulk container form containing Acetaminophen 325 mg, Guaifenesin 200 mg, and Phenylephrine HCl 5 mg (NDC 62959-106-00). The recall covers approximately 33,758,436 tablets affected by multiple lot codes.

The recall was initiated because the product was manufactured with Current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to 3 distributors, who may have distributed finished product to retailers or other customers.

Affected lot codes include: - Product Code C106L: lots 18J080, 18L029, 19A103, 19B063, 19D019, 19F065 - Product Code C106LA: lots 18K045, 18K046, 18L008, 18L105, 19A068, 19A094, 19A106, 19B009, 19C031, 19C032, 19C033, 19G085, 19H070, 19D018, 19H071, 19H082, 19J027

If you have this product, contact your supplier or ULTRAtab Laboratories, Inc. for further instructions. Do not use the product. The FDA classified this as a Class II recall, which the firm initiated voluntarily on January 26, 2022.

The recalled product

Product
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Drug — Cold/Cough
Hazard
  • cgmp-deviation
  • manufacturing-defect

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 (20)

  • Product Code C106L
  • Bulk lots: 18J080
  • 18L029
  • 19A103
  • 19B063
  • 19D019
  • 19F065
  • Product Code C106LA
  • Bulk lots: 18K045
  • 18K046
  • 18L008
  • 18L105
  • 19A068
  • 19A094
  • 19A106
  • 19B009
  • 19C031
  • 19C032
  • 19C033
  • 19G085

Distribution

Distribution scope not specified by the agency.

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