Home / Recalls / VistaPharm LLC / D-0126-2024

D-0126-2024 Class III Terminated

Recalled by VistaPharm LLC — Largo, FL

Recall Details

Product Type
Drugs
Report Date
December 6, 2023
Initiation Date
October 17, 2023
Termination Date
July 26, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Prod Lot number 22ZKY1, EXP 11/27/23, 600 bottles dist; 22ZMC1 EXP12/21/23 600 bottles; 22ZTP1 EXP 03/29/24 588 bottles; 23ZAD1 EXP 07/07/24 564 bottl

Product Description

Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08

Reason for Recall

Failed Excipient Specifications: high content of ethylene glycol (EG)

Distribution Pattern

Nationwide USA

Code Information

Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.

Other recalls by VistaPharm LLC

  • D-0093-2024 Class III — Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manu (October 26, 2023)
  • D-0047-2024 Class I — Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles p (October 18, 2023)
  • D-1149-2023 Class II — Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bot (August 30, 2023)
  • D-0018-2023 Class II — Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in (September 30, 2022)
  • D-0376-2022 Class II — Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: V (January 7, 2022)
  • D-0019-2021 Class III — NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (B (September 25, 2020)
  • D-1377-2020 Class III — Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Ma (June 23, 2020)
  • D-1378-2020 Class III — Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. o (June 23, 2020)
  • D-0348-2019 Class III — NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in (November 30, 2018)
  • D-1139-2017 Class III — Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL ( (August 17, 2017)