RecallRadar

FDA Drug recall D-0020-2016

Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52…

On 2015-10-21 the FDA classified a Class III recall of Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52… by Ohm Laboratories, citing superpotent Drug: Out Of Specification (OOS) result for Assay.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0020-2016
ClassificationClass III
Statusterminated
Initiated2015-07-28
Published2015-10-21
Last updated2026-09-13 11:51 UTC
CompanyOhm Laboratories
DistributionUS

Product

Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.

Reason

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Identifiers

upc011822527125
upc011822536721
code_info
Batch Numbers: a) 2658137, Exp 11/30/2016; 2644272, Exp 9/30/2016; 2625093, 2625092 Exp 6/30/2016; 2617892, Exp 5/31…Batch Numbers: a) 2658137, Exp 11/30/2016; 2644272, Exp 9/30/2016; 2625093, 2625092 Exp 6/30/2016; 2617892, Exp 5/31/2016; 2610783, Exp 4/30/2016; 2600126, 2600128, Exp 2/29/2016 b) 2625093, Exp 6/30/2016; 2617892, Exp 5/31/2016; 2600128, Exp 2/29/2016

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0020-2016%22

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