Class II · Moderate risk
Claritin Allergy Liq Chldrns Grape 2 Floz Sku 900834 Claritin…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Loratadine 24 HR-OTC
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00
Affected NDC
54868-5268-00
Compare with the code on your package — it is the most precise check available.
Drug: Loratadine Category: Allergy & Cold Medication
- Recalling firm
- Physicians Total Care, Inc.
- NDC code
- 54868-5268-00
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0239-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Loratadine recalls
See all
Class III · Low risk
AllerClear D-24 hr
Failed Moisture Limits
Class III · Low risk
Loratadine-D Extended-Release Tablets
Failed Moisture Limits
Class II · Moderate risk
Children's Loratadine Oral Solution USP
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Loratadine 10mg 100 Nd 24h
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Physicians Total Care, Inc.
All 2013 recalls
Class II · Moderate risk
Cephalexin Monohydrate Capsules
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Class II · Moderate risk
Carisoprodol IV
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Class II · Moderate risk
Belladonna Alkaloids/PB
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
Class III · Low risk
Camila 0.35 mg Tablets
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.