Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported March 28, 2018
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
Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Pine Pharmaceuticals, LLC recalled Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pha… - a low-severity action.
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pha… was recalled by Pine Pharmaceuticals, LLC in March 28, 2018. Reason: Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained activ…. Check the official notice for the remedy. Verify recall #D-0607-2018 with the FDA Drug before acting.
The recall
Pine Pharmaceuticals, LLC issued this low-severity FDA Drug recall-Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained activ….
- Low
- severity level
- 136 units
- affected scope
- Class III
- classification
- March 28, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0607-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0607-2018) was formally reported on March 28, 2018, with the manufacturer initiating the action on March 5, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Pine Pharmaceuticals, LLC is listed as the recalling firm, operating out of Tonawanda, NY. Federal records list the affected scope as 136 units.
The documented reason for this recall is: Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product. Distribution data in the federal record shows the product reached: NY only. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
136 units
Related Recalls
6
5 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0607-2018 |
| Date reported | March 28, 2018 |
| Date initiated | March 5, 2018 |
| Recalling firm | Pine Pharmaceuticals, LLC |
| Firm location | Tonawanda, NY |
| Affected scope | 136 units |
| Distribution | NY only |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0607-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pine Pharmaceuticals, LLC. Units affected: 136 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on March 28, 2018. Severity: Low. Recall number: D-0607-2018.
Where was the recalled product distributed? ▼
Distribution: NY only.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0607-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 28, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.