The Recall Desk
SevereFDA (Drugs)·D-1527-2012·Announced 2012-08-22

Franck's Lab Recalls Sterile G-C-P Solutions Due to Microbial Contamination

Franck's Lab Inc. is recalling sterile G-C-P solutions because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection from non-sterile medical products.

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The specific products involved are G-C-P 0.1%/0.1%/0.05% Solution in 250 mL, 250 mLs, and 500 mL sizes. The recall covers a total of 6 units.

The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This lack of assurance of sterility poses a risk to patients who may have received the affected medications.

The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Patients who have received these products should contact their healthcare provider for further instructions.

The recalled product

Product
G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)
Manufacturer
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Category
Drug — Sterile Compounded Medication
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Rx #'s: 0400975 0409215 0395770 0359811

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 100 products in this recall →

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