Class II · Moderate risk
Bisacodyl Suppositories
CGMP Deviations: products were stored outside the drug label specifications.
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02
Affected NDC
52268-0523-02
Compare with the code on your package — it is the most precise check available.
Drug: Bisacodyl
- Recalling firm
- Braintree Laboratories Inc.
- NDC code
- 52268-523-02
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-911-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Bisacodyl recalls
See all
Class II · Moderate risk
Qp Laxative Bisacodyl 5 Mg Tablet 50 Ct Sku 902449 Qp Women…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Bisacodyl Suppositories
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Laxative Suppositories
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Biscolax Laxative
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Other packaging defect recalls from 2013
All packaging defect recalls
Class III · Low risk
Qnasl (beclomethasone dipropionate)
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Class II · Moderate risk
Acetaminophen suspension liquid
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Class II · Moderate risk
Acetaminophen suspension liquid
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Class II · Moderate risk
Acetaminophen suspension liquid
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
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