The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1449-2012·Announced 2012-08-22

Franck's Lab Recalls Acetylcysteine Ophthalmic Solutions Due to Sterility Concerns

Franck's Lab Inc. is recalling specific acetylcysteine ophthalmic solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, and the presence of microorganisms and fungal growth in a sterile product manufacturing environment poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling six different products of Acetylcysteine, Ophthalmic in Artificial Tears. The affected products include 10% solutions in 10 ml, 2 ml, 5 ml, and 6 ml containers; a 2.5% solution in 20 ml containers; and a 5% solution in 3 ml containers. The recall covers 16 units of these sterile human drugs.

The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where the sterile products were prepared. This lack of assurance of sterility affects all sterile human drugs distributed by the company between November 21, 2011, and May 21, 2012.

The products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Specific prescription numbers associated with the recall include 0398691, 0401304, 0403533, 0385192, 0407592, 0394079, 0388572, 0391271, and 0400529. Consumers should stop using these products and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 2.5% SOLUTION 20 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 5% SOLUTION 3 ML (6 DIFFERENT PRODUCTS)
Manufacturer
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Category
Drug — Ophthalmic Solution
Hazard
Affected units
16

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 (9)

  • Rx #'s: 0398691
  • 0401304
  • 0403533
  • 0385192
  • 0407592
  • 0394079
  • 0388572
  • 0391271
  • 0400529

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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