VistaPharm recalls
FDA enforcement reports naming VistaPharm LLC as the recalling firm.
- Recall reports
- 36
- Class I (serious)
- 1
- Most recent report
- Dec 6, 2023
- Dec 6, 2023Aminocaproic Acid Oral Solution, 0Drug · VistaPharm LLCFailed Excipient Specifications: high content of ethylene glycol (EG)Class III
- Nov 15, 2023Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufacture…Drug · VistaPharm LLCDefective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.Class III
- Oct 25, 2023Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case…Drug · VistaPharm LLCMicrobial Contamination of Non-Sterile Products: identified as Bacillus cereus.Class I
- Sep 20, 2023Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), R…Drug · VistaPharm LLCSuperpotent/Subpotent single ingredient Drug: Out of Specification Assay resultsClass II
- Nov 2, 2022Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL uni…Drug · VistaPharm, Inc.cGMP Deviations: Out of specification for assay of one of the preservative ingredients.Class II
- Jan 26, 2022Clobazam Oral Suspension 2Drug · VistaPharm, Inc.Failed Stability SpecificationsClass II
- Oct 14, 2020NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0Drug · VistaPharm, Inc.Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lotClass III
- Jul 15, 2020Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactu…Drug · VistaPharm, Inc.Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.Class III
- Jul 15, 2020Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 flDrug · VistaPharm, Inc.Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.Class III
- Dec 26, 2018NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50…Drug · VistaPharm, Inc.Failed Impurities/Degradation Specifications:Out of specification for impurities.Class III
- Hydrocodone Bitartrate and Acetaminophen Oral Solution 7
- Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose…
- Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cup…
- Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl
- Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit d…
- Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl
- Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case
- Nystatin Oral Suspension, USP 500,000 Units/5 mL, a)
- Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manuf…
- Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manuf…
- Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a)
- Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a
- Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000…
- Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per cas…
- Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx…
- Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7
- Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged…
- Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrin…
- METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only
- METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups…
- Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Onl…
- Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufa…
- METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufact…
- Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups,…
- Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VI…
- Hydrocodone Bitartrate & Acetaminophen Oral Solution 7
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