Status
Terminated
Drug Enforcement D-750-2014
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
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Classification
Class II
Report Date
January 29, 2014
Termination Date
November 4, 2014
Product Information
- Product description
- Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UPC 3 0043-6403-24 7); b) 12-count packets per carton containing 6-count Daytime and 6-count Nighttime packets (UPC 3 0043-6403-12 4); Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.
- Product quantity
- 917,400 cartons
- Reason for recall
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Location & Firm
- Recalling firm
- Novartis Consumer Health
- Address
-
10401 Hwy 6
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-750-2014
- Event ID
- 65490
- Recall initiation date
- June 18, 2013
- Center classification date
- January 17, 2014
- Code info
- Lot #: a) 25777303, 25777304, Exp 5/31/2013; 25777501, 25777502, Exp 6/30/2013; 25777801, 25777802, Exp 7/31/2013; 25777803, 25981801, 25981802, Exp 8/31/2013; 25981803, 26088801, 26088802, Exp 9/30/2013; b) 25596201, 25596202, 25596203, 25596204, 25596205, 25596206, Exp 5/31/2013; 25596207, 25767001, 25767101, 25767102, 25767103, Exp 6/30/2013; 25767002, 25767104, 25767105, 25767106, 25767201, Exp 7/31/2013; 25767202, 25767203, 25767204, 25767205, 25767206, 25981602, 25981603, 25981604, 25981605, Exp 8/31/2013; 25981601, Exp 9/30/2013
- More code info
- —