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D-0222-2025 Class III Terminated

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

FDA drug recall D-0222-2025 was initiated by PAI Holdings, LLC. dba Pharmaceutical Associates Inc on January 7, 2025 and is designated Class III. Reason for recall: Superpotent; sodium benzoate preservative The recall status is terminated (terminated July 25, 2026). Affected quantity: 4080 Bottles.

Recall Details

Product Type
Drugs
Report Date
February 12, 2025
Initiation Date
January 7, 2025
Termination Date
July 25, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4080 Bottles

Product Description

Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16

Reason for Recall

Superpotent; sodium benzoate preservative

Distribution Pattern

OH

Code Information

Lot number 4B07, Exp Date: 2026-OCT-31

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

  • 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-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)

FDA data resources