Recalls / Class II
Class IID-0233-2017
Product
Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639
- Affected lot / code info
- Lot # 35254; Exp. 05/20
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Raritan Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8 Joanna Ct, N/A, East Brunswick, New Jersey 08816-2108
Distribution
- Quantity
- 22,704 bottles
- Distribution pattern
- NY
Timeline
- Recall initiated
- 2016-11-18
- FDA classified
- 2016-12-23
- Posted by FDA
- 2017-01-04
- Terminated
- 2020-01-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0233-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.