May 2018 FDA Recall Nystatin by Pharmaceutical Associates Inc
D-0865-2018 - Resuspension problems
This Class III drug recall was voluntarily initiated by Pharmaceutical Associates Inc on May 29, 2018 for the product Nystatin. The FDA reported the reason for recall as resuspension problems. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0865-2018
Resuspension problems: Out of specification for appearance and resuspendability.
05-29-2018
06-13-2018
275400 cups
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pharmaceutical Associates Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-13-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
Batch or Lot Expiration Information
Lot# Lot: B5B8 Exp. 07/2019
