Class II · Moderate risk
Claritin Allergy Liq Chldrns Grape 2 Floz Sku 900834 Claritin…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Children's Loratadine Syrup
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.
Affected NDC
51672-2092-08
Compare with the code on your package — it is the most precise check available.
Drug: Loratadine Category: Allergy & Cold Medication
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0383-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 Taro Pharmaceuticals U.S.A., Inc.
All 2014 recalls
Class III · Low risk
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Class I · High risk
Clobetasol Propionate Ointment USP
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class II · Moderate risk
Nortriptyline HCl Capsules
CGMP deviations.
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