The Recall Desk
SevereFDA (Drugs)·D-1453-2012·Announced 2012-08-22

Recall of Sterile Alteplase Syringes Due to Microbial Contamination

Franck's Lab Inc. is recalling sterile alteplase syringes distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

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, and the hazard involves a lack of assurance of sterility in injectable drugs, which carries a significant risk of serious injury or infection.

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling 16 units of sterile alteplase syringes. The affected products were distributed nationwide and to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies between November 21, 2011, and May 21, 2012.

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 of infection to patients receiving the injections.

Patients who received these specific syringes should contact their healthcare provider for evaluation. The recall covers specific prescription numbers listed in the agency's records, including 0392878, 0398614, and 0394932.

The recalled product

Product
ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (10MCG/0.1ML) INJECTA 0.15 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML; ALTEPLASE, SD
Manufacturer
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Category
Drug — Injectable Sterile Drug
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 (12)

  • Rx #'s: 0392878
  • 0398614
  • 0394932
  • 0387461
  • 0352013
  • 0391247
  • 0391792
  • 0399973
  • 0401614
  • 0402893
  • 0392721
  • 0382234

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 →

Related recalls

Same manufacturer · Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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Same hazard · microbial contamination

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