Vistapharm recalls

Vistapharm appears in 36 official U.S. recall notices indexed by RecallRadar, most recently on 2023-12-06.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recall notices	36
Published	2012-07-18 to 2023-12-06
By agency	FDA Drug (36)
By classification	Class II (25), Class III (10), Class I (1)
By status	terminated (36)
Distribution named in notices	AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, US, UT, VA, WA, WI, WV

Recalls

Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc.,…
FDA Drug · Class III · 2023-12-06 · Vistapharm
Reason: Failed Excipient Specifications: high content of ethylene glycol (EG)
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#6…
FDA Drug · Class III · 2023-11-15 · Vistapharm
Reason: Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPh…
FDA Drug · Class I · 2023-10-25 · Vistapharm
Reason: Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm,…
FDA Drug · Class II · 2023-09-20 · Vistapharm
Reason: Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689…
FDA Drug · Class II · 2022-11-02 · Vistapharm
Reason: cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc
FDA Drug · Class II · 2022-01-26 · Vistapharm
Reason: Failed Stability Specifications
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: Vis…
FDA Drug · Class III · 2020-10-14 · Vistapharm
Reason: Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037…
FDA Drug · Class III · 2020-07-15 · Vistapharm
Reason: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manuf…
FDA Drug · Class III · 2020-07-15 · Vistapharm
Reason: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 tr…
FDA Drug · Class III · 2018-12-26 · Vistapharm
Reason: Failed Impurities/Degradation Specifications:Out of specification for impurities.
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by:…
FDA Drug · Class III · 2017-09-20 · Vistapharm
Reason: Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Lar…
FDA Drug · Class II · 2017-08-09 · Vistapharm
Reason: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo,…
FDA Drug · Class II · 2017-08-09 · Vistapharm
Reason: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individua…
FDA Drug · Class III · 2017-06-07 · Vistapharm
Reason: Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per ca…
FDA Drug · Class II · 2017-02-15 · Vistapharm
Reason: Defective Container: Leakage of unit dose cups that may occur at the seal.
Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 6668…
FDA Drug · Class II · 2017-02-08 · Vistapharm
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 b…
FDA Drug · Class II · 2017-02-08 · Vistapharm
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771,…
FDA Drug · Class II · 2017-02-08 · Vistapharm
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter…
FDA Drug · Class II · 2017-02-08 · Vistapharm
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-…
FDA Drug · Class II · 2017-02-08 · Vistapharm
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of…
FDA Drug · Class II · 2017-02-08 · Vistapharm
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by V…
FDA Drug · Class II · 2017-02-08 · Vistapharm
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC…
FDA Drug · Class II · 2017-02-08 · Vistapharm
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 1…
FDA Drug · Class II · 2017-02-08 · Vistapharm
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 6668…
FDA Drug · Class II · 2017-02-08 · Vistapharm
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33…
FDA Drug · Class II · 2017-02-08 · Vistapharm
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039…
FDA Drug · Class II · 2016-11-30 · Vistapharm
Reason: Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (…
FDA Drug · Class II · 2016-05-11 · Vistapharm
Reason: Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only
FDA Drug · Class III · 2015-10-07 · Vistapharm
Reason: Defective Container: Lids on unit dose cups are not fully qualified.
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only
FDA Drug · Class II · 2014-10-15 · Vistapharm
Reason: Defective Container: Product leaks when inverted.
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, F…
FDA Drug · Class II · 2013-12-18 · Vistapharm
Reason: Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc
FDA Drug · Class II · 2013-08-28 · Vistapharm
Reason: Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771
FDA Drug · Class III · 2012-09-05 · Vistapharm
Reason: Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC…
FDA Drug · Class II · 2012-08-29 · Vistapharm
Reason: Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture ca…
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
FDA Drug · Class II · 2012-08-08 · Vistapharm
Reason: Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture ca…
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473…
FDA Drug · Class II · 2012-07-18 · Vistapharm
Reason: Impurities/Degradation Products: exceeded specification at 3 month stability testing