Why it was recalled
CGMP Deviations
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 35254; Exp. 05/20
Where it was sold
NY
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-0233-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 18, 2016
- FDA report date
- Jan 4, 2017
- Quantity
- 22,704 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Raritan Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0233-2017, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75757
- Address
- 8 Joanna Ct
- Code information
- Lot # 35254; Exp. 05/20
- Postal code
- 08816-2108
- Report date
- Jan 4, 2017
- Product type
- Drugs
- Recall number
- D-0233-2017
- Classification
- Class II
- Recalling firm
- Raritan Pharmaceuticals, Inc.
- Product quantity
- 22,704 bottles
- Termination date
- Jan 8, 2020
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- NY
- Recall initiation date
- Nov 18, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2016