Class III · Low risk
Chlordiazepoxide HCl/Clidinium Bromide capsules
Failed Impurities/Degradation Specifications
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.
Affected NDC
0187-4100-10
Compare with the code on your package — it is the most precise check available.
Drug: Chlordiazepoxide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Librax Chlordiazepoxide Hydrochloride and Clidinium Bromide NDC 00187-4100 |
CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1; CLIDINIUM BROMIDE 2.5 mg/1 | Capsule Oral |
Bausch Health US, LLC | Rx |
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- NDC code
- 0187-4100-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1034-2016 · 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 Chlordiazepoxide recalls
See all
Class II · Moderate risk
chlordiazePOXIDE HCl
Labeling: Label Mixup: chlordiazePOXIDE HCl, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 50 mg, NDC 65162064110, Pedigree: AD46414_16, EXP: 5/16/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD49463_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, 0 mg, NDC 49100036374, Pedigree: W003173, EXP: 6/13/2014.
Other recalls by Valeant Pharmaceuticals North America LLC
All 2015 recalls
Class III · Low risk
Diltiazem HCl CD capsules
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Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
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