Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit Recalled for Defective Bottle
Braintree Laboratories is recalling 10,362 cartons of HalfLytely and Bisacodyl Tablet Bowel Prep Kits due to micro-fractures in the 2-liter bottle that cause leaks.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is a packaging defect (leak) rather than a direct health risk like contamination or injury.
Plain-English summary
Braintree Laboratories Inc. is recalling 10,362 cartons of Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (NDC 52268-523-02). The affected product is identified by Lot 3013002 with an expiration date of 08/14. The recall covers a nationwide distribution.
The recall was initiated because a small micro-fracture was observed in the 2-liter bottle at the fill line. This defect results in a small leak when the patient reconstitutes the bulk powder. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02
- Manufacturer
- Braintree Laboratories Inc.
- Category
- Drug — Bowel Prep
- Hazard
- Affected units
- 10,362
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)
- Lot 3013002 Exp. 08/14
Distribution
Distribution scope not specified by the agency.
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