Class II · Moderate risk
Claritin Allergy Liq Chldrns Grape 2 Floz Sku 900834 Claritin…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Loratadine Orally Disintegrating Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)
Drug: Loratadine Category: Allergy & Cold Medication
- Recalling firm
- Ohm Laboratories, Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1142-2015 · 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 Ohm Laboratories, Inc.
All 2015 recalls
Class III · Low risk
Meijer Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Wal-itin Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Sunmark loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Up&Up loratadine orally disintegrating tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
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