Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuti...
FDA Drug Recall #D-0607-2018 — Class III — March 5, 2018
Recall Summary
| Recall Number | D-0607-2018 |
| Classification | Class III — Low risk |
| Date Initiated | March 5, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pine Pharmaceuticals, LLC |
| Location | Tonawanda, NY |
| Product Type | Drugs |
| Quantity | 136 units |
Product Description
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01
Reason for Recall
Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Distribution Pattern
NY only
Lot / Code Information
Lot#: 18098@1, Exp. 7/16/2018
Other Recalls from Pine Pharmaceuticals, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0059-2024 | Class II | Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose... | Oct 2, 2023 |
| D-0057-2024 | Class II | Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe,... | Oct 2, 2023 |
| D-0058-2024 | Class II | Moxifloxacin in Balanced Salt Solution 400 mcg/... | Oct 2, 2023 |
| D-0061-2024 | Class II | Calcium chloride Solution for Intravenous Injec... | Oct 2, 2023 |
| D-0055-2024 | Class II | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.... | Oct 2, 2023 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.