Why it was recalled
Subpotent
Product description
Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284
Lot numbers, UPCs & expiration codes
Batch #: 1404811, 1409802, 1502817, 1504808, 1509810, 1511802, 1603801, Exp. 12/12/2018.
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-0674-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 5, 2017
- FDA report date
- Apr 26, 2017
- Quantity
- Approximately 7,920,177 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InnovaGel
Original FDA data
Every field from FDA enforcement report D-0674-2017, 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 #: 1404811, 1409802, 1502817, 1504808, 1509810, 1511802, 1603801, Exp. 12/12/2018.
- Postal code
- 33186-6013
- Report date
- Apr 26, 2017
- Product type
- Drugs
- Recall number
- D-0674-2017
- Classification
- Class III
- Recalling firm
- InnovaGel
- Product quantity
- Approximately 7,920,177 capsules
- Termination date
- Sep 29, 2021
- Reason for recall
- Subpotent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284
- Distribution pattern
- NY only
- Recall initiation date
- Jan 5, 2017
- Initial firm notification
- Telephone
- Center classification date
- Apr 19, 2017