Why it was recalled
Subpotent
Product description
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
Lot numbers, UPCs & expiration codes
Batch #: 1508803,1602801, 1602802, 1604801, 1604802, 1606801, 1606802, 1606803, 1606804, Exp. 08/03/2018.
Where it was sold
NY only
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0675-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 5, 2017
- FDA report date
- Apr 26, 2017
- Quantity
- 9,992,768 softgels
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InnovaGel
Original FDA data
Every field from FDA enforcement report D-0675-2017, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 76933
- Address
- 14193 Sw 119th Ave
- Code information
- Batch #: 1508803,1602801, 1602802, 1604801, 1604802, 1606801, 1606802, 1606803, 1606804, Exp. 08/03/2018.
- Postal code
- 33186-6013
- Report date
- Apr 26, 2017
- Product type
- Drugs
- Recall number
- D-0675-2017
- Classification
- Class III
- Recalling firm
- InnovaGel
- Product quantity
- 9,992,768 softgels
- Termination date
- Sep 29, 2021
- Reason for recall
- Subpotent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- NY only
- Recall initiation date
- Jan 5, 2017
- Initial firm notification
- Telephone
- Center classification date
- Apr 19, 2017