March 2020 FDA Recall Nystatin by Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
D-1060-2020 - SubPotent Drug
This Class II drug recall was voluntarily initiated by Pai Holdings, Llc. Dba Pharmaceutical Associates Inc on March 19, 2020 for the product Nystatin. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1060-2020
SubPotent Drug: Low out-of-specification results for assay testing.
03-19-2020
04-01-2020
7416 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.
PAI Holdings, LLC. dba 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 in the USA.
09-22-2021
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) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
Batch or Lot Expiration Information
Lot# Lot: BE85, Exp. 11/2020
