Severity
Low
FDA Drug recall · Reported October 21, 2015
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Ohm Laboratories, Inc. recalled Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-… - a low-severity action.
Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-… was recalled by Ohm Laboratories, Inc. in October 21, 2015. Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.. Check the official notice for the remedy. Verify recall #D-0020-2016 with the FDA Drug before acting.
The recall
Ohm Laboratories, Inc. issued this low-severity FDA Drug recall-Superpotent Drug: Out Of Specification (OOS) result for Assay..
Sourced from official FDA Drug enforcement records. Verify recall #D-0020-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0020-2016) was formally reported on October 21, 2015, with the manufacturer initiating the action on July 28, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Ohm Laboratories, Inc. is listed as the recalling firm, operating out of North Brunswick, NJ. Federal records list the affected scope as 90,410 units.
The documented reason for this recall is: Superpotent Drug: Out Of Specification (OOS) result for Assay. Distribution data in the federal record shows the product reached: Nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
90,410 units
Related Recalls
6
5 from same agency
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.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0020-2016 |
| Date reported | October 21, 2015 |
| Date initiated | July 28, 2015 |
| Recalling firm | Ohm Laboratories, Inc. |
| Firm location | North Brunswick, NJ |
| Affected scope | 90,410 units |
| Distribution | Nationwide. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 21, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.