The Recall Desk
Agency classClass IIIOur severity:LowFDA (Food)·F-0925-2015·Announced 2015-02-04

Thera Tablets with Beta Carotene Recalled for Missing Labeling Information

The Harvard Drug Group is recalling Thera Tablets with Beta Carotene because some blister cards are missing product information on the back.

The agency’s classification

FDA (Food): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a remote possibility of adverse health consequences. The issue is a packaging and labeling defect where information is missing from the back of the blister card, which falls under the 'packaging-only problems' criterion for a Low severity score.

Plain-English summary

The Harvard Drug Group, LLC is recalling 5,700 unit doses of Thera Tablets with Beta Carotene Dietary Supplement. The recall involves 10 x 10 cartons with Lot Number M-00953 and an expiration date of 06-2015.

The recall was initiated after the firm received a complaint on December 16, 2014, stating that blister packets were missing labeling information. An investigation confirmed that six 2 x 5 blister cards inside a carton were missing some or all of the product information on the back of the blister card.

The affected products were distributed domestically in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. Consumers should check their products for the specific lot number and expiration date and contact the firm for instructions if they possess the affected items.

The recalled product

Product
Thera Tablets with Beta Carotene Dietary Supplement
Manufacturer
The Harvard Drug Group, LLC
Category
Food — Dietary Supplement
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 Number: M-00953 Expiration Date: 06-2015
  • UPC Code: 3 09040 53961 8

Distribution

Distributed in 27 states:

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