Why it was recalled
Presence of Foreign Tablets/Capsules.
Product description
Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01
Lot numbers, UPCs & expiration codes
Lot 172291
Where it was sold
Nationwide in the USA
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-0091-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 24, 2017
- FDA report date
- Nov 29, 2017
- Quantity
- 74 cartons (cartons of 100 individual unit doses)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services
Original FDA data
Every field from FDA enforcement report D-0091-2018, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 78490
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot 172291
- Postal code
- 43217-1188
- Report date
- Nov 29, 2017
- Product type
- Drugs
- Recall number
- D-0091-2018
- Classification
- Class II
- Recalling firm
- Amerisource Health Services
- Product quantity
- 74 cartons (cartons of 100 individual unit doses)
- Termination date
- Jun 19, 2018
- Reason for recall
- Presence of Foreign Tablets/Capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 24, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2017