Franck's Lab Recalls Sterile Oxytocin Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile oxytocin injectable products distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the manufacturing 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 presence of microorganisms and fungal growth in sterile injectable drugs poses a significant risk of serious injury or hospitalization due to infection.
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 identified in the recall notice are OXYTOCIN 10UNITS/ML INJECTABLE 25 ML and OXYTOCIN (25X1ML) 10U/ML INJECTABLE 25 MLS. The recall is driven by a lack of assurance of sterility.
The U.S. Food and Drug Administration (FDA) conducted environmental sampling in the clean room where these sterile products were prepared. The sampling revealed the presence of microorganisms and fungal growth. This contamination indicates that the sterile products may not be sterile, posing a risk of infection to patients.
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. The recall covers prescription numbers 0398994 and 0387653. Patients and healthcare providers should stop using these products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- OXYTOCIN 10UNITS/ML INJECTABLE 25 ML; OXYTOCIN**(25X1ML) 10U/ML INJECTABLE 25 MLS (2 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Injectable
- Affected units
- 2
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: 0398994 0387653
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 98 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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