Reckitt Benckiser LLC Recalls
Showing 1-13 of 13 recalls
Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
On December 19, 2018, the firm issued Urgent Medical Device Recall letters to wholesale customers. The letter advised customers of the product issue, and reminded customers that the product labeling states, "Should a condom break or leak during use, seek medical assistance as soon as possible, at least within 72 hrs." Customers are asked to do the following: 1. Examine inventory in your distribution center immediately to determine if you have the specified batch in your warehouse inventory. 2. Segregate and return the specified batch. 3. A pre-paid return label is provided by the firm for your convenience to return the product. Contact Stericycle Expert Solutions at 888-843-0252 for assistance if you need additional labels or help with coordination of pickup and removal of product from your facility. Contact Information: Phone: 888-843-0252 Fax: 855-880-6687 Email: rbhealth3552@stericycle.com 4. Alternatively, you may arrange shipment of product directly to Stericycle at the following address: Attn: Event 3552 2670 Executive Drive, Suite A Indianapolis, IN 46241 Dock Hours are 8AM - 4:30PM Monday - Friday Please call to schedule a dock appointment 5. Finally, notify Stericycle representative by completing and returning the Business Response Form via email rbhealth3552@stericycle.com that you have: a. Checked your inventory in your distribution centers and confirm you have NO product of the specified batch. b. You have collected all units in your inventory and product has been shipped back in accordance with the instructions from your Stericycle representative. Please direct any questions or concerns with this recall to Stericycle Representative at 877-448-5308 and reference event 3552. For general inquiry not related to the recall, please contact RB Custo er Service Director, Robert Drennan at 201-220-8531.
Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
The products failed the filed specification of 1.0kPa for Burst Pressure.
On 7/23/18, an Urgent Medical Device Recall notification letter was distributed to customers. The letter instructed customers to do the following: 1. Examine your inventory in your distribution center immediately to determine if you have the specified batch in your warehouse inventory. 2. Segregate and quarantine the specified batch. 3. If you have product of the specified batch, contact our Stericycle representative immediately for a RETURN AUTHORIZATION number. a. Contact Information: Phone: 877-448-5308 Fax: 877-884-9410 4. Contact Stericycle Expert Solutions at 877-448-5308 for assistance with coordination of pickup and removal of product from your facility. If arranging pick up of product, freight will be prepaid by Stericycle. A pre-paid return label has been included for your convenience. Alternatively, you may arrange shipment of product directly to Stericycle at the following address: Attn: Event 4241 2670 Executive Drive, Suite A Indianapolis, IN 46241 Dock Hours are SAM -4:30PM Monday- Friday Please call to schedule a dock appointment 5. Finally, notify Stericycle representative via email RB4241@stericycle.com that you have: a. Checked your inventory in your distribution centers and confirm you have NO product of the specified batch b. You have collected all units in your inventory and product has been shipped back in accordance with the instructions from your Stericycle representative. On 7/26/18, a second Urgent Medical Device Recall notification letter was sent to customers which included two additional batches included in the recall. This letter included the same customer instructions as the 7/23/18 letter.
Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)
Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.
Reckitt Benckiser LLC sent an Urgent Medical Device Recall letter/business response form dated November 22, 2016 to the affected customers. Stericylcle is handling returns.
Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
On August 6,. 2018, Reckitt Benckiser issued Urgent Medical Device Recall notices to customers. Customers were advised to take the following action: Wholesale Customers: 1. Examine inventory and quarantine affected product 2. Contact customers and notify them of the recall and provide them with the recall instructions (copy of the letter). 3. Customers are encouraged to contact Stericycle Expert Solutions at 877-448-5308 for assistance if additional return labels are required or help with coordination of pickup and removal of product from your facility.
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-01966-9, UPC 63824-52622-5
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360 mL), For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-526-22
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, Phenylephrine HCl Nasal Decongestant, 6 fl oz. (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-500-66, UPC 63824-50066-09
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OTC, Distributed by Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch