VistaPharm LLC recalls Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm,…
Failed Excipient Specifications: high content of ethylene glycol (EG)
Read the official notice →- Date
- 2023-12-06
- Country
- United States
- Brand
- VistaPharm
- Product
- Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm,…
- Classification
- Class III
- Units
- Nationwide USA
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More VistaPharm recalls
- 2023-11-15
USVistaPharm LLC recalls Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA,…
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
- 2023-10-25
- US
VistaPharm LLC recalls Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by:…
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
- 2023-09-20
- US
VistaPharm LLC recalls Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by:…
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
- 2022-11-02
- US
VistaPharm, Inc. recalls Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC…
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
- 2022-01-26
- US
VistaPharm, Inc. recalls Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
Failed Stability Specifications
FDA · DrugVistaPharm, Inc.Nationwide within the United States including Puerto RicoOfficial notice →
Other drugs & medical recalls in the United States
- 2023-12-06
- US
Bayer Healthcare Pharmaceuticals Inc. recalls VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals…
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
FDA · DrugBayer Healthcare Pharmaceuticals Inc.Product was distributed to specialty pharmacies and distributors nationwide…Official notice → - US
Golden State Medical Supply Inc. recalls PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90;…
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
- US
- US
Fagron Compounding Services recalls Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For…
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
- US
Glenmark Pharmaceuticals Inc., USA recalls Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa…
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
- US
Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2,…
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine