Recall: D-0633-2018

Class II - Potentially Harmful

Class IIClassification

2018-03-30Initiated

TerminatedStatus

AVKARE Inc.Firm

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

Reason

Failed Dissolution Specifications

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.