Class II · Moderate risk
Unisom
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Allergy Relief Diphenhydramine HCl 25 mg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
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
Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3.
Affected NDCs
11673-0720-24
36800-0483-24
42507-0483-24
49738-0483-24
Compare with the code on your package — it is the most precise check available.
Drug: Diphenhydramine Category: Allergy & Cold Medication
- Recalling firm
- P & L Development, LLC
- NDC code
- 36800-483-24
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0694-2017 · 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 Diphenhydramine recalls
See all
Class II · Moderate risk
Unisom
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Class III · Low risk
Diphenhydramine HCl 50 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Diphenhydramine HCl 25 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Diphenhydramine HCl 25 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Other wrong potency / content recalls from 2017
All wrong potency / content recalls
Class III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity Specifications
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class II · Moderate risk
Viokace (pancrelipase)
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
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