Recalls / Class II
Class IID-763-2014
Product
Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)
- Affected lot / code info
- Lot #: Russia product: 10117513,10117515, 10117517, 10117520, 10118676, 10118680, Exp 6/30/2013 and Former Soviet Union product: 10116986, 10116988, Exp 8/31/2013.
Why it was recalled
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Recalling firm
- Firm
- Novartis Consumer Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10401 Hwy 6, Lincoln, Nebraska 68517-9626
Distribution
- Distribution pattern
- Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Timeline
- Recall initiated
- 2013-06-18
- FDA classified
- 2014-01-17
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-763-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.