InvaGen Pharmaceuticals Issues Voluntary Nationwide Recall of Vigabatrin for Oral Solution, USP 500mg due to Leaking Sachets
2023-12-09
上市批准
HAUPPAUGE, N.Y., Dec. 9, 2023 /PRNewswire/ -- Cipla Limited today announced that its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc. is voluntarily recalling one lot of Vigabatrin for Oral Solution, USP 500mg, to the consumer level. Vigabatrin for Oral Solution, USP 500 mg has been found to have seal integrity issues allowing for powder leakage from the pouch.
An improper seal in the pouch may lead to the leakage of powder blend outside the pouch, resulting in a lower content of medicine inside the pouch compared to the label claim and result in potential underdosing. The population at risk is primarily infants and young children. In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening seizures requiring immediate emergency room treatment. Cipla has not received any reports of adverse events related to this recall.
The product is used for the treatment of Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded adequately to several alternative treatments. Vigabatrin for oral solution is not indicated as a first-line agent. The medication is packaged in foil pouches, each containing 500mg of Vigabatrin, and there are 50 foil sealed pouches in a shelf pack. The affected lot is NB301030, with an expiration date of 03/2025. The Vigabatrin for Oral Solution, USP 500mg product was distributed nationwide to partnered distributors and consignees.
InvaGen Pharmaceuticals is notifying the customer level through press releases, letters, telefax, telephone, email, and on-site visits, and is coordinating the return of all recalled products. Distributors, retailers and consumers in possession of Vigabatrin for Oral Solution, USP 500mg Batch No. NB301030, NDC# 6909-7964-53 are advised to initiate the return process through their respective place of purchase.
Consumers with questions regarding this recall can contact Cipla by phone number 844- CIPLAUS (844-247-5287) M-F 8:30 AM-5:00 PM EST, or email [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this batch of drug product.
Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report
Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
DISCLAIMER
SOURCE Cipla USA
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