Product Safety Recalls

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APIS MELLIFERA Recall D-1164-2023

Description: TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19.

APIS MELLIFERA Recall D-1164-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1164-2023
Event ID92974
BrandRED EYE RELIEF PF
Generic NameAPIS MELLIFERA, EUPHRASIA STRICTA, CALCIUM SULFIDE, LOESELIA MEXICANA WHOLE, PULSATILLA VULGARIS
ManufacturerAPIS MELLIFERA, EUPHRASIA STRICTA, CALCIUM SULFIDE, LOESELIA MEXICANA WHOLE, PULSATILLA VULGARIS
Original Package?1
Active SubstanceAPIS MELLIFERA CALCIUM SULFIDE
Drug RouteOPHTHALMIC
DistributionProduct was distributed to two (2) direct accounts in RI and CO.
Quantity196,442 units
Recall ReasonLack of Assurance of Sterility
Drug ClassificationClass II
Drug Code Info20230927
Product NDC17312-095
Product NUIN0000185021 N0000175629 N0000184306
Drug UPC0858961001952
Pharma Class (PE)Increased Histamine Release [PE]
Pharma Class (EPC)Standardized Insect Venom Allergenic Extract [EPC]
Pharma Class (CS)Allergens [CS]
Recall Initiation Date20230901
Report Date20230927
Classification Date20230915
AddressBuilding 108Street A3, King Abdullah Ii Industrial City
Amman,  
Jordan
Recalling FirmAMMAN PHARMACEUTICAL INDUSTRIES
Initial Notification Letter
Unique Ingredient Identifier7S82P3R43Z 1MBW07J51Q
Structured Product Labeling (SPL ID)f55151c9-5eb2-44f7-e053-2a95a90a8472
Structured Product Labeling (SPL Set ID)e5d7debd-4caf-d611-e053-2a95a90ad458
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