Class III · Low risk
Meijer Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS
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
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.
Affected NDCs
36800-0527-69
36800-0528-69
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Ohm Laboratories, Inc.
- NDC code
- 36800-528-69
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0035-2016 · 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 recalls by Ohm Laboratories, Inc.
All 2015 recalls
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.
Other wrong potency / content recalls from 2015
All wrong potency / content recalls
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk
Lindane Lotion
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Class I · High risk
Vitamin Supplement
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
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