The recall was initiated due to stability failure that was discovered during the annual stability program for the product. A total of 3 lots had Out Of Specification (OOS) test results for Impurity “Chlordiazepoxide Related compound A (lactam)” at expiry (48 months) after testing by the new validated analytical test method. The OOS levels of lactam may cause adverse health effects such as excessive drowsiness or dizziness. In addition, lactam can cause short-term synergistic effects of chlordiazepoxide; long-term effects may arise as levels accumulate in the body. It can further cross the cerebrospinal fluid (CSF) and placental barrier and it is also excreted in breast milk.
Librax capsules are packaged in 100-count bottles with NDC 68682-409-10 (Generic) and 00187-4100-10 (Brand). Valeant stated all the distributed batches with 48 months expiration period will be recalled. Those in possession of the recalled products should quarantine and arrange for return.
Librax combines chlordiazepoxide HCl, a benzodiazepine, and clidinium bromide, an anticholinergic. It is indicated for adjunct treatment in peptic ulcer and for the treatment of irritable bowel syndrome.
For more information call (888) 216-7326 or visit Valeant.com.