The Recall Desk
ModerateFDA (Drugs)·D-0526-2022·Announced 2022-02-16

Drug recall: Kramer Novis Tusicof caplet CGMP deviations

ULTRAtab Laboratories is recalling Kramer Novis Tusicof caplets due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 639,729 tablets distributed to three wholesalers.

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 recall is classified as FDA Class II, but the source text does not report any illnesses, hospitalizations, or injuries. CGMP deviations are manufacturing quality failures and not inherently linked to patient harm in the source text. Per the rubric, Class II recalls without reported illness are scored as Moderate (2).

Plain-English summary

ULTRAtab Laboratories, Inc., headquartered in Highland, New York, is recalling Kramer Novis Tusicof caplets in bulk containers. Each caplet contains Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, and Phenylephrine HCl 10 mg (NDC 62959-124-00). The recall was initiated on January 26, 2022, and covers approximately 639,729 tablets.

The recall was issued because the bulk product did not comply with current Good Manufacturing Practice (CGMP) requirements. The affected product codes are C119L, with bulk lots 18K028. ULTRAtab distributed the bulk product to three distributors, who may have subsequently distributed finished products to retailers or other entities.

This is a voluntary recall initiated by the firm through a letter to the FDA. The FDA classified this as a Class II recall. Consumers who have obtained this product should not use it and should return it to the place of purchase. Healthcare providers should notify their patients if they have distributed this product.

The recalled product

Product
Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Drug — Cough and Cold
Hazard
  • cgmp-violation
  • manufacturing-deviation

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: C119L Bulk Lots: 18K028

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category