Drug & medication recalls Moderate risk

Family Dollar Stores product recalled over manufacturing violations

Recall date
June 23, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Family Dollar Stores, Llc. recalls ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU 999543 ORAJEL ORAL PAIN 0.125 FL OZ…
Recall number
D-1381-2022
FDA classification
Class II
Brand / firm
Family Dollar Stores, Llc.
Sold / distributed
Nationwide within the United States

Why it was recalled

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU 999543 ORAJEL ORAL PAIN 0.125 FL OZ SKU 912968 ORAJEL MOUTH SORE GEL 0.125 OZ SKU 999075 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

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