Drug Enforcement D-1156-2023

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

September 27, 2023

Termination Date

Product Information

Product description
TRP Natural Eyes, Dryness 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: 17312-096-19.
Product quantity
83,898 units
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Product was distributed to two (2) direct accounts in RI and CO.

Location & Firm

Recalling firm
AMMAN PHARMACEUTICAL INDUSTRIES
Address
Building 108, Street A3, King Abdullah Ii Industrial City

Jordan
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-1156-2023
Event ID
92974
Recall initiation date
September 1, 2023
Center classification date
September 15, 2023
Code info
Lot: FR001 EXP: 07/24; Lot: FR004 EXP: 04/25; Lot:FR005 EXP: 04/25; Lot:FR006 EXP: 04/25; Lot: FR007 Exp: 04/25
More code info