The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1039-2016·Announced 2016-06-29

Profarma Recalls tabcin ACTIVE M.R. Capsules Due to Manufacturing Deviations

Profarma Distributors LLC is voluntarily recalling 42 boxes of tabcin ACTIVE M.R. 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 aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/manufacturing errors without reported serious injury.

Plain-English summary

Profarma Distributors LLC is voluntarily recalling 42 boxes (504 capsules) of tabcin ACTIVE M.R. Capsules, 12-count boxes. The product is identified by Lot # 224TS and an expiration date of 02/17. The recall was initiated on May 11, 2016, and the product was distributed nationwide.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. The FDA 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 this product should stop using it and contact Profarma Distributors LLC for further instructions. The recall status is currently terminated.

The recalled product

Product
tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
Manufacturer
Profarma Distributors LLC
Category
Drug — Antibiotic
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 # 224TS
  • Exp. 02/17

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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