Why it was recalled
Failed Dissolution Specifications
Product description
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
Lot numbers, UPCs & expiration codes
Lot: 16719 Exp. 07/2018
Where it was sold
Nationwide
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-0633-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 30, 2018
- FDA report date
- Apr 25, 2018
- Quantity
- 2135 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-0633-2018, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 79680
- Address
- 615 N 1st St
- Code information
- Lot: 16719 Exp. 07/2018
- Postal code
- 38478-2403
- Report date
- Apr 25, 2018
- Product type
- Drugs
- Recall number
- D-0633-2018
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Product quantity
- 2135 cartons
- Termination date
- Jun 4, 2020
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 30, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 17, 2018