Home / Recalls / PAI Holdings, LLC. dba Pharmaceutical Associates Inc / D-0721-2021

D-0721-2021 Class II Terminated

Recalled by PAI Holdings, LLC. dba Pharmaceutical Associates Inc — Greenville, SC

Recall Details

Product Type
Drugs
Report Date
August 18, 2021
Initiation Date
July 29, 2021
Termination Date
December 2, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)

Product Description

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

Reason for Recall

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022

Other recalls by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

  • D-0222-2025 Class III — Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl (January 7, 2025)
  • D-0722-2021 Class II — Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, P (July 29, 2021)
  • D-0723-2021 Class II — Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmac (July 29, 2021)
  • D-0015-2021 Class III — Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg fo (September 9, 2020)
  • D-1494-2020 Class II — Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 (August 4, 2020)
  • D-1060-2020 Class II — Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 1 (March 19, 2020)