Virtus Pharmaceuticals Opco Ii L
Complete recall history across all FDA and CPSC categories — 7 total recalls
Virtus Pharmaceuticals Opco Ii L appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (7)
FDA drug safety enforcement actions by Virtus Pharmaceuticals Opco Ii L
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 12, 2016 | VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FD... | Class III |
| Dec 12, 2016 | Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing ... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FD... | Class III |
| Dec 12, 2016 | Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Min... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FD... | Class III |
| Dec 12, 2016 | Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Di... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FD... | Class III |
| Sep 2, 2016 | Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx ... | Failed Content Uniformity Specifications: resulting in both superpotent and s... | Class I |
| Sep 2, 2016 | Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only,... | Failed Content Uniformity Specifications: resulting in both superpotent and s... | Class I |
| Sep 2, 2016 | Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottl... | Failed Content Uniformity Specifications: resulting in both superpotent and s... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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