Why it was recalled
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Product description
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
Lot numbers, UPCs & expiration codes
Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0964-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 10, 2014
- FDA report date
- Apr 29, 2015
- Quantity
- 155 cases (2000 pouches of 2 tablets per case)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Reckitt Benckiser LLC
Original FDA data
Every field from FDA enforcement report D-0964-2015, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70840
- Address
- 399 Interpace Pkwy
- Code information
- Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016
- Postal code
- 07054-1133
- Report date
- Apr 29, 2015
- Product type
- Drugs
- Recall number
- D-0964-2015
- Classification
- Class III
- Recalling firm
- Reckitt Benckiser LLC
- Product quantity
- 155 cases (2000 pouches of 2 tablets per case)
- Termination date
- Mar 30, 2018
- Reason for recall
- Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 10, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 21, 2015