Westlab Pharmacy, Inc.
FDA Regulatory Profile
Westlab Pharmacy, Inc. has 3 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0090-2019 · Class II · Aug 10, 2018
- Latest inspection
- Oct 5, 2021 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 3 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0090-2019 | Class II | ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%… | Aug 10, 2018 |
| D-0091-2019 | Class II | Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92 | Aug 10, 2018 |
| D-0089-2019 | Class II | Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC… | Aug 10, 2018 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3007426960 | Gainesville, FL | 2 | Oct 5, 2021 |