ScieGen Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg and 300 Mg

HAUPPAUGE, N.Y., October 29, 2018 (Newswire.com) - ScieGen Pharmaceuticals Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity,

The impurity - N-nitrosodiethylamine (NDEA), contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited - is a substance that occurs naturally in certain foods, drinking water, air pollution and industrial processes and has been classified as a "probable human carcinogen as per International Agency for Research on Cancer (IARC)." 

To date, Sciegen Pharmaceuticals Inc. has not received any reports of adverse events related to this product.

"Irbesartan tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents." 

Irbesartan Tablets, USP 75 mg, 150 mg and 300 mg were manufactured by ScieGen Pharmaceuticals Inc. and are labeled as "Westminster Pharmaceuticals" and "Golden State Medical Supply, Inc. [GSMS]."  

The recalls and returns will be managed by the respective distributors separately for the lots distributed by them as outlined below.

Details of batches sent to Westminster

The Irbesartan tablets subject to recall are packed in 30-count and 90-count bottles. To help identify the recalled product, the NDCs, product description, lot numbers and expiration dates are listed below. These lots were distributed nationwide in the USA to Westminster’s direct accounts.

NDC#	Product Description	Lot#	Expiration Date
69367-119-01	Irbesartan 75mg Tablets, 30 count bottle	B160002A	Sep-19
69367-119-03	Irbesartan 75mg Tablets, 90 count bottle	B160002B	Sep-19
69367-120-01	Irbesartan 150mg Tablets, 30 count bottle	B161005A	Sep-19
69367-120-01	Irbesartan 150mg Tablets, 30 count bottle	C161002A	Feb-20
69367-120-03	Irbesartan 150mg Tablets, 90 count bottle	B161005B	Sep-19
69367-120-03	Irbesartan 150mg Tablets, 90 count bottle	C161002B	Feb-20
69367-121-01	Irbesartan 300mg Tablets, 30 count bottle	B162008A	Sep-19
69367-121-01	Irbesartan 300mg Tablets, 30 count bottle	C162002A	Feb-20
69367-121-03	Irbesartan 300mg Tablets, 90 count bottle	B162008B	Sep-19
69367-121-03	Irbesartan 300mg Tablets, 90 count bottle	C162002B	Feb-20

Westminster is notifying its direct accounts by email and by phone to immediately discontinue distribution of the product being recalled and to notify their wholesale and retail accounts of this product recall and make arrangements for impacted product to be returned to Westminster. Instructions for returning recalled products are provided in the Recall Notice Letter and Recall Response Form. Patients should return the affected medication to their pharmacy. Pharmacies should return their affected stock to their wholesaler.

For anyone taking Irbesartan, please examine the tablets and look for the specific markings to determine if the product is affected by this recall. "Products can be best identified by patients as being white, oval shaped tablets debossed with SG 160; SG 161; or SG 162." 

Customers and patients with medical-related questions, information about an adverse event or other questions about Westminster’s products being recalled should contact Westminster’s Regulatory Affairs department by phone at 888-354-9939.

• Live calls are received Monday-Friday, 9 a.m.-5 p.m. EST with voicemail available 24 hours/day, seven days/week or email recalls@wprx.com.

Details of batches sent to Golden State Medical Supply, Inc. [GSMS] 

The products subject to recall are packed in 30-count and 90-count bottles. To help identify the recalled product, the NDCs, product description, lot numbers and expiration dates are listed below. These lots were distributed nationwide in the USA to GSMS’ direct accounts.  

NDC#	Product Description	Lot#	Expiration Date
60429-641-30	Irbesartan 150mg Tablets, 30 Count Bottle	GS019526	Nov-19
60429-641-30	Irbesartan 150mg Tablets, 30 Count Bottle	GS020252	Nov-19
60429-641-30	Irbesartan 150mg Tablets, 30 Count Bottle	GS020958	Nov-19
60429-642-30	Irbesartan 300mg Tablets, 30 Count Bottle	GS019036	Sep-19
60429-642-30	Irbesartan 300mg Tablets, 30 Count Bottle	GS019073	Sep-19
60429-642-30	Irbesartan 300mg Tablets, 30 Count Bottle	GS021472	Nov-19
60429-642-30	Irbesartan 300mg Tablets, 30 Count Bottle	GS021530	Nov-19
60429-642-30	Irbesartan 300mg Tablets, 30 Count Bottle	GS022234	Feb-20
60429-640-90	Irbesartan 75mg Tablets, 90 Count Bottle	B160003	Sep-19
60429-640-90	Irbesartan 75mg Tablets, 90 Count Bottle	B160004	Sep-19
60429-641-90	Irbesartan 150mg Tablets, 90 Count Bottle	B161003	Sep-19
60429-641-90	Irbesartan 150mg Tablets, 90 Count Bottle	B161004	Sep-19
60429-641-90	Irbesartan 150mg Tablets, 90 Count Bottle	B161006	Sep-19
60429-641-90	Irbesartan 150mg Tablets, 90 Count Bottle	B161007	Sep-19
60429-641-90	Irbesartan 150mg Tablets, 90 Count Bottle	B161008	Nov-19
60429-641-90	Irbesartan 150mg Tablets, 90 Count Bottle	B161009	Nov-19
60429-641-90	Irbesartan 150mg Tablets, 90 Count Bottle	B161010	Nov-19
60429-641-90	Irbesartan 150mg Tablets, 90 Count Bottle	C161001	Feb-20
60429-641-90	Irbesartan 150mg Tablets, 90 Count Bottle	C161003	May-20
60429-642-90	Irbesartan 300mg Tablets, 90 Count Bottle	B162009	Sep-19
60429-642-90	Irbesartan 300mg Tablets, 90 Count Bottle	B162010	Sep-19
60429-642-90	Irbesartan 300mg Tablets, 90 Count Bottle	B162011	Sep-19
60429-642-90	Irbesartan 300mg Tablets, 90 Count Bottle	B162012	Nov-19
60429-642-90	Irbesartan 300mg Tablets, 90 Count Bottle	B162013	Nov-19
60429-642-90	Irbesartan 300mg Tablets, 90 Count Bottle	B162014	Nov-19
60429-642-90	Irbesartan 300mg Tablets, 90 Count Bottle	B162015	Nov-19
60429-642-90	Irbesartan 300mg Tablets, 90 Count Bottle	C162001	Feb-20

Complete the Recall Inventory Response Form and return to Golden State Medical Supply Incorporated by email at recalls@gsms.us or by via fax at (805) 477-9869. Contact Golden State Medical Supply Incorporated for directions on return authorizations by calling (800) 284-8633 ext. 215 between 7:30 a.m.-4 p.m. Pacific or email recalls@gsms.us.

For anyone taking Irbesartan, please examine the tablets and look for the specific markings to determine if the product is affected by this recall. "Products can be best identified by patients as being white, oval shaped tablets debossed with SG 160; SG 161; or SG 162." 

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on Irbesartan should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Irbesartan.

Adverse reactions or quality problems experienced with the use of this product may 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 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 made with the knowledge of the Food and Drug Administration.

Source: ScieGen Pharmaceuticals Inc.