Recalls / Class II
Class IID-0633-2018
Product
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
- Brand name
- Amantadine Hcl
- Generic name
- Amantadine Hydrochloride
- Active ingredient
- Amantadine Hydrochloride
- Route
- Oral
- NDC
- 50268-069
- FDA application
- ANDA078720
- Affected lot / code info
- Lot: 16719 Exp. 07/2018
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- AVKARE Inc.
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 2135 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-03-30
- FDA classified
- 2018-04-17
- Posted by FDA
- 2018-04-25
- Terminated
- 2020-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0633-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.