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U.S. Department of Health and Human Services

Class 3 Device Recall GSK

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  Class 3 Device Recall GSK see related information
Date Initiated by Firm April 25, 2016
Date Posted July 11, 2016
Recall Status1 Terminated 3 on July 19, 2017
Recall Number Z-2148-2016
Recall Event ID 74030
Product Classification Breathing - Nasal Strips - Product Code N/A
Product Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
Code Information Shipper case lot #8008580, Retal Carton Lot #4543U8008580
Recalling Firm/
Manufacturer		 GSK Consumer Healthcare
184 Liberty Corner Rd Ste 200
Warren NJ 07059-6868
Manufacturer Reason
for Recall		 Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrectly labeled for cartons intended for the AU/NZ market.
FDA Determined
Cause 2		 Error in labeling
Action GSK Consumer Healthcare sent an Urgent - Product Recall Letter dated April 4, 2016, to all affected customers and an updated recall letter dated April 25, 2016, via FedEx. The recall letters identified the product and problem. The April 25, 2016, was sent to further clarify, the lot number on the Breathe Right carton. The customers were asked to immediately examine their inventory, quarantine and cease distribution of the specific lot of the affected product. Customers were asked to carry out a physical count and record the data on the response form. The response form should be returned to GSK within five (5) business days, even if you do not have the recalled lot. The response form should be faxed to (336) 499-8795. If customer needs shipping assistance or questions about the recall process, they can call 1-844-722-2104, and refer to Event Number 535STRIPS16. If any customer has questions, they can direct them to GSK Consumer Healthcare Consumer Relations team at 800-858-6673.
Quantity in Commerce 1,440 cases ( 34, 560 retail - units )
Distribution US Nationwide
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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