Multi-event July 2021 FDA Recall Ethosuximide by Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
This Multi-event Class II drug recall was voluntarily initiated by Pai Holdings, Llc. Dba Pharmaceutical Associates Inc on July 29, 2021 for the product Ethosuximide. The FDA reported the reason for recall as lack of cgmp. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0721-2021
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
07-29-2021
08-18-2021
a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
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.
Distributed Nationwide in the USA
12-02-2022
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, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
Batch or Lot Expiration Information
Lot# Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022
Affected Packages Involved in this Recall
Recall Number: D-0722-2021
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
07-29-2021
08-18-2021
400 cases (12 bottles/case)
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.
Distributed Nationwide in the USA
12-02-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
Batch or Lot Expiration Information
Lot# Lot: C62F Exp. 31OCT2022
Recall Number: D-0723-2021
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
07-29-2021
08-18-2021
75 cases (6 bottles/case)
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.
Distributed Nationwide in the USA
12-02-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16
Batch or Lot Expiration Information
Lot# Lot: C9BC Exp. 31OCT2022
