ModerateClass IITerminated

FDA Drug recall · Reported August 22, 2012

FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL INJECTABLE 23 VIAL, 25 VIAL, 30 VIAL, 7 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/5MG VIAL INJECTABLE 1 VIAL, 10 VIAL, 12 VIAL, 13 VIAL, 15 VIAL, 2 VIAL, 20 VIAL, 24 VIAL, 3 VIAL, 30 VIAL, 40 VIAL, 41 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 7 VIAL, 9 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/5MG VIAL INJECTABLE 10 VIAL, 15 VIAL, 20 VIAL; FLUORESCEI

Q: Which agency issued this recall?

This recall was issued by the FDA Drug on August 22, 2012. Severity: Moderate. Recall number: D-1519-2012.

Q: Where was the recalled product distributed?

Distribution: Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies.

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (D-1519-2012) 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.

Q: 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.

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling re…

Recall #: D-1519-2012
Affected scope: 202 units
Initiated: May 25, 2012

Compiled from official public sources by the editorial team. · Updated July 2026

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Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalled FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL… - a moderate-severity action.

FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL… was recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab in August 22, 2012. Reason: Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed b…. Check the official notice for the remedy. Verify recall #D-1519-2012 with the FDA Drug before acting.

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The recall

Franck's Lab Inc., d.b.a. Franck's Compounding Lab issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed b….

Moderate
severity level: 202 units
affected scope: Class II
classification: August 22, 2012
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1519-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-1519-2012) was formally reported on August 22, 2012, with the manufacturer initiating the action on May 25, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Franck's Lab Inc., d.b.a. Franck's Compounding Lab is listed as the recalling firm, operating out of Ocala, FL. Federal records list the affected scope as 202 units.

The documented reason for this recall is: Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms an… Distribution data in the federal record shows the product reached: Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. 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.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

202 units

Related Recalls

5 from same agency

Product description

FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL INJECTABLE 23 VIAL, 25 VIAL, 30 VIAL, 7 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/5MG VIAL INJECTABLE 1 VIAL, 10 VIAL, 12 VIAL, 13 VIAL, 15 VIAL, 2 VIAL, 20 VIAL, 24 VIAL, 3 VIAL, 30 VIAL, 40 VIAL, 41 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 7 VIAL, 9 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/5MG VIAL INJECTABLE 10 VIAL, 15 VIAL, 20 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/7.5MG VIAL INJECTABLE 20 vials, 6 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 400MG/15MG VIAL INJECTABLE 10 VIAL, 14 VIAL, 15 VIAL, 16 VIAL, 2 VIAL, 20 VIAL, 21 VIAL, 25 VIAL, 250 VIAL, 3 VIAL, 30 VIAL, 32 VIAL, 4 VIAL, 40 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 8 VIALS, 9 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 500MG/25MG VIAL INJECTABLE 1 VIAL, 12 VIAL, 2 VIAL, 23 VIAL, 30 VIAL, 6 VIAL, 8 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 600MG/12.5MG VIAL INJECTABLE 58 VIAL, 680 VIAL, 692 VIAL, 724 VIAL, 750 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 600MG/15MG VIAL INJECTABLE 2 VIAL, 3 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHYLIZED 1000MG/10MG INJECTABLE 100 VIAL, 137 VIAL, 140 VIAL, 153 VIAL, 200 VIAL, 47 VIAL, 60 VIAL, 63 VIAL (70 DIFFEENT PRODUCTS)

Reason for recall

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	D-1519-2012
Date reported	August 22, 2012
Date initiated	May 25, 2012
Recalling firm	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Firm location	Ocala, FL
Affected scope	202 units
Distribution	Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

202 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-1519-2012) 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? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 22, 2012. Severity: Moderate. Recall number: D-1519-2012.

Where was the recalled product distributed? ▼

Distribution: Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (D-1519-2012) 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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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

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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 August 22, 2012. 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.