FDADecember 12, 2022drug
ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
cGMP Deviations
What to do
FDA enforcement status: Terminated
Brands named
atlantic management resourcesatlanticatlantic management
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAKii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB232025-12-11
- FDANeuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-012025-08-27
- FDADubai emek SPREAD PISTACHIO CACAO CREAM WITH KADAYIF NET WT. 9.7oz UPC 8 69652 10130 1 Manufacturer: Emek Dogal Saglik Urunlerilkl. Gida Turkey2025-07-14
- CPSCInterior Resources Recalls Children's Steel Utility Bunk Beds Due to Risk of Serious Injury or Death from Entrapment Hazards; Violations of Federal Regulations for Bunk Beds (Recall Alert)2025-03-27
- FDAHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia2024-12-16
- FDAHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia2024-12-16
- FDAHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia2024-12-16
- FDAAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.2024-12-04
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