Home / Recalls / PAI Holdings, LLC. dba Pharmaceutical Associates Inc / D-1060-2020

D-1060-2020 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
April 1, 2020
Initiation Date
March 19, 2020
Termination Date
September 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7416 bottles

Product Description

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.

Reason for Recall

SubPotent Drug: Low out-of-specification results for assay testing.

Distribution Pattern

Nationwide in the USA.

Code Information

Lot: BE85, Exp. 11/2020

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-0721-2021 Class II — Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx (July 29, 2021)
  • 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)