CLASS II Drug recall · Reported 4 Jan 2017 · FDA Enforcement Report
Kids' Relief Ear Relief Oral Liquid 3025 de'l Assomption Blvd recalled
Raritan Pharmaceuticals is recalling Kids' Relief Ear Relief Oral Liquid 3025 de'l Assomption Blvd, 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-0233-2017
- 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
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
Where it was distributed
NY
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # 35254; Exp. 05/20
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 75757| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CVS pharmacy Kids' Ear Relief Oral Liquid recalled | Raritan Pharmaceuticals | Manufacturing (CGMP) Deviations | NY | |
| CLASS II | CVS Health Homeopathic Infants Teething Tablets recalled | Raritan Pharmaceuticals | Manufacturing (CGMP) Deviations | NY |
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 | CVS pharmacy Kids' Ear Relief Oral Liquid 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 |