InnovaGel Recalls Subpotent Dye Free Allergy Softgel Gelatin Capsules
InnovaGel is voluntarily recalling Dye Free Allergy Softgel Gelatin Capsules because they are subpotent. The affected product was distributed in New York.
The agency’s classification
FDA (Drugs): 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 FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
InnovaGel is voluntarily recalling Dye Free Allergy Softgel Gelatin Capsules, 15,000-count bulk drums. The recall was initiated on January 5, 2017, and the product is identified by Product Code MSU0067P and NDC 6897080284. The specific batches affected are 1508803, 1602801, 1602802, 1604801, 1604802, 1606801, 1606802, 1606803, and 1606804, all with an expiration date of 08/03/2018.
The reason for the recall is that the product is subpotent, meaning it does not contain the full amount of the active ingredient as labeled. The total quantity of product involved is 9,992,768 softgels. The distribution pattern for this recall is limited to New York only.
The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. The recall status is currently terminated.
The recalled product
- Product
- Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284
- Manufacturer
- InnovaGel
- Category
- Drug — Pharmaceutical Capsules
- Hazard
- Affected units
- 9,992,768
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 (10)
- Batch #: 1508803
- 1602801
- 1602802
- 1604801
- 1604802
- 1606801
- 1606802
- 1606803
- 1606804
- Exp. 08/03/2018.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by InnovaGel 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 2 products in this recall →Related recalls
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