ORLANDO, Florida., March 11, 2022 /PRNewswire-PRWeb/ — Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin and NAD formulations, consumer level injectable compounds. These composite products were found to be out of specification.
Risk Statement: Administration of subpotent hydroxocobalamin to infants, pregnant/lactating women, and elderly populations poses a risk of vitamin B12 deficiency and there is a reasonable likelihood that they may experience adverse effects, including muscle weakness, numbness or peripheral neuropathic pain, loss of vision, and psychiatric disorders (depression, memory loss). Additionally, compounded injectable products, which contain more or less drug product than the strength stated on the label, or which reconstitute at a different rate than intended, may result in the delivery of too much or too little drug. This could lead to lower than expected drug efficacy or unexpected adverse side effects.
Olympia Pharmacy has not received any patient reports or concerns regarding the safety of the recalled compound sterile products, and no patient reports of adverse reactions attributed to any of the recalled compound sterile products.
The recalled compound products are generally prescribed by healthcare professionals for the management of age, erectile dysfunction, vitamin deficiencies and for diagnostic imaging of the gallbladder. Affected lots include the following lot numbers and expiration dates listed below. The product can be identified by reading the lot number in the black area of the label and has been distributed to patients and health clinics.
Medicine Bottle size Batch Best before date
NAD 500mg vial C41008 03/08/22
NAD 500mg vial D24005 04/05/22
Vial of Sincalide 5 mcg D24001 04/01/22
Trimix Formula F9 Bottle 10ml D41C19 04/19/22
Sermorelin Acetate 9mg 9mg vial D44026 04/26/22
Sermorelin acetate 9 mg 9 mg vial F42104 06/04/22
Trimix T-105, 5ml bottle E41F10 05/10/22
Trimix T-105, 10ml bottle E41G10 05/10/22
Trimix SB-4 5ml bottle E41C18 05/18/22
Trimix SB-4 10ml bottle E41D18 05/18/22
Hydroxocobalamin 1mg/ml Bottle of 30 ml E47025 05/21/22
Olympia Pharmacy is notifying customers by mail and arranging for the return and replacement of all recalled compound products. Patients and health clinics who have any of the listed compound products that are subject to recall should stop using and return to Olympia Pharmacy.
Consumers with questions regarding this recall may contact Olympia Pharmacy by phone at 407-250-4000 or email [email protected] Monday through Friday from 9 a.m. to 6 p.m. Eastern Standard Time.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch adverse event reporting program either online, by regular mail, or by fax.
This recall is being conducted with the knowledge of the United States Food and Drug Administration.
Callback Coordinator, Olympus Pharmacy1 4072504000, [email protected]
SOURCE Olympia Pharmacy