January 2020 FDA Recall Nystatin by Pharmaceutical Associates Inc
D-0824-2020 - Subpotent
This Class II drug recall was voluntarily initiated by Pharmaceutical Associates Inc on January 14, 2020 for the product Nystatin. The FDA reported the reason for recall as subpotent. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0824-2020
Subpotent: Out of specification for assay at the 12-month time point.
01-14-2020
02-05-2020
6288 16 oz bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Distributed Nationwide in the US
06-03-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
Batch or Lot Expiration Information
Lot# Lots: BB70, BB71 Exp. May 2020
