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D-1494-2020 Class II Terminated

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

FDA drug recall D-1494-2020 was initiated by PAI Holdings, LLC. dba Pharmaceutical Associates Inc on August 4, 2020 and is designated Class II. Reason for recall: Subpotent drug: Out of specification for assay at the 15-month test interval. The recall status is terminated (terminated September 22, 2021). Affected quantity: 7416 bottles.

Recall Details

Product Type
Drugs
Report Date
August 19, 2020
Initiation Date
August 4, 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), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16

Reason for Recall

Subpotent drug: Out of specification for assay at the 15-month test interval.

Distribution Pattern

Nationwide USA

Code Information

Lot: B973, Exp 11/20

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-0721-2021 Class II — Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx (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-1060-2020 Class II — Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 1 (March 19, 2020)

FDA data resources