CLASS III Drug recall · Reported 28 Mar 2018 · FDA Enforcement Report
Brilliant Blue G for Intraocular Injection vial 0.25 mg/mL recalled
Pine Pharmaceuticals is recalling Brilliant Blue G for Intraocular Injection vial 0.25 mg/mL Compounded by: Pine, distributed in New York. The recall was initiated on 5 Mar 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0607-2018
- FDA event ID
- 79457
- Recalling firm
- Pine Pharmaceuticals, Tonawanda, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Mar 2018
- FDA classified
- 26 Mar 2018
- Reported
- 28 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Mar 2018 | Recall initiated by company | |
| 26 Mar 2018 | Classified by FDA | +21 days |
| 28 Mar 2018 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
NY only
Questions about this recall
Why was it recalled?
Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Which lots are affected?
Lot#: 18098@1, Exp. 7/16/2018
Where was it sold?
NY only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Bevacizumab 1.25 MG/ Solution for Injection syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic recalled | Pine Pharmaceuticals | Sterility | Nationwide |