CLASS II Drug recall · Reported 4 Jan 2017 · FDA Enforcement Report
CVS pharmacy Kids' Ear Relief Oral Liquid recalled
Raritan Pharmaceuticals is recalling CVS pharmacy Kids' Ear Relief Oral Liquid, distributed in New York. The recall was initiated on 18 Nov 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0234-2017
- FDA event ID
- 75757
- Recalling firm
- Raritan Pharmaceuticals, East Brunswick, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Nov 2016
- FDA classified
- 23 Dec 2016
- Reported
- 4 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 18 Nov 2016 | Recall initiated by company | |
| 23 Dec 2016 | Classified by FDA | +35 days |
| 4 Jan 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639
Where it was distributed
NY
Stores named: CVS
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # 33149; Exp. 01/20
Where was it sold?
NY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 75757This product is part of a recall event; the main page for the event is Kids' Relief Ear Relief Oral Liquid 3025 de'l Assomption Blvd recalled.
More recalls from Raritan Pharmaceuticals
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | CVS Health Homeopathic Infants Teething Tablets recalled | Raritan Pharmaceuticals | Manufacturing (CGMP) Deviations | NY |
| Drug | CLASS II | Kids' Relief Ear Relief Oral Liquid 3025 de'l Assomption Blvd recalled | Raritan Pharmaceuticals | Manufacturing (CGMP) Deviations | NY |
| Drug | CLASS II | Simply Right Healthcare Fiber Capsules recalled | Raritan Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk recalled | Raritan Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Premier Value Fiber Plus Calcium Supplement Capsules recalled | Raritan Pharmaceuticals | Sterility | Nationwide |