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Class III: unlikely to cause harmTerminated

Braintree HalfLytely and Bisacodyl Tablet Recall

Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02

Braintree Laboratories Inc. · Holbrook, MA

Risk level
Class III
Reported by FDA
Aug 28, 2013
Recall ID
D-911-2013
Check your lot numberHow we source this data

Summary

Braintree Laboratories recalled Braintree HalfLytely and Bisacodyl Tablet starting Jul 15, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-911-2013 on Aug 28, 2013. Reason: Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder. Status: Terminated.

Why it was recalled

Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder

Product description

Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02

Lot numbers, UPCs & expiration codes

Lot 3013002 Exp. 08/14

Where it was sold

Nationwie

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-911-2013
Classification
Class III
Status
Terminated
Recall initiated
Jul 15, 2013
FDA report date
Aug 28, 2013
Quantity
10,362 kit cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Braintree Laboratories Inc.

Original FDA data

Every field from FDA enforcement report D-911-2013, exactly as published.

Show all FDA fields
City
Holbrook
State
MA
Status
Terminated
Country
United States
Event ID
65676
Address
270 Centre St
Code information
Lot 3013002 Exp. 08/14
Postal code
02343-1073
Report date
Aug 28, 2013
Product type
Drugs
Recall number
D-911-2013
Classification
Class III
Recalling firm
Braintree Laboratories Inc.
Product quantity
10,362 kit cartons
Termination date
Jan 21, 2014
Reason for recall
Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder
Voluntary / mandated
Voluntary: Firm initiated
Product description
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02
Distribution pattern
Nationwie
Recall initiation date
Jul 15, 2013
Initial firm notification
Letter
Center classification date
Aug 20, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-911-2013, published Aug 28, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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