The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1040-2016·Announced 2016-06-29

Profarma Recalls tabcin NOCHE Capsules Due to Manufacturing Deviations

Profarma Distributors LLC is recalling 31 boxes of tabcin NOCHE capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

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 CGMP deviations, which typically indicates a risk of temporary or medically reversible adverse health consequences, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls without reported serious injury.

Plain-English summary

Profarma Distributors LLC is voluntarily recalling 31 boxes (372 capsules) of tabcin NOCHE capsules, 12-count boxes. The affected product is identified by Lot # X223FS and an expiration date of 11/17. The recall was initiated on May 11, 2016, and the product was distributed nationwide.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The recall was initiated by the firm and was terminated on January 24, 2017.

Consumers who have the affected product should stop using it and contact Profarma Distributors LLC for further instructions. The recall status is currently terminated.

The recalled product

Product
tabcin NOCHE; Capsules,12-count box, UPC 501008485033
Manufacturer
Profarma Distributors LLC
Category
Drug — Pharmaceutical
Hazard

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 # X223FS
  • Exp. 11/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Profarma Distributors LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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