Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms 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 involves a lack of assurance of sterility in injectable drugs, which carries a risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling specific sterile human drugs, including Atropine Sulfate and Atropine/Epinephrine/BSS injectables. The recall covers 32 units of these products distributed nationwide and to several international locations, including the Bahamas, Colombia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.
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 contaminated injections.
Healthcare providers and patients who have received these products should contact their healthcare provider for guidance. The affected products were distributed between November 21, 2011, and May 21, 2012.
The recalled product
- Product
- ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML, 5 ML (8 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Injectable
- Affected units
- 32
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 (14)
- Rx #'s: 0398523
- 0404345
- 0404347
- 0404348
- 0404349
- 0404351
- 0406460
- 0384921
- 0395199
- 0399779
- 0379708
- 0389329
- 0409506
- 0378436
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.
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