Medicine recalls
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| The United States: Olympia Pharmacy issues voluntary nationwide recall of seven compounded products due to being out-of-specification |
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The US Food and Drug Administration (FDA) announces that Olympia Pharmacy is voluntarily recalling 11 specific lots of the following compounded injectables to the consumer level. These compounded products were found to be out-of-specification. The affected products are:
- NAD, 500mg vial (lot number: C41008, D24005)
- Sincalide, 5mcg vial (lot number: D24001)
- Trimix Formula F9, 10ml vial (lot number: D41C19)
- Sermorelin Acetate, 9mg vial (lot numeber: D44026, F42104)
- Trimix T-105, 5 ml vial (lot number: E41F10)
- Trimix T-105, 10ml vial (lot number: E41G10)
- Trimix SB-4, 5ml vial (lot number: E41C18)
- Trimix SB-4, 10ml vial (lot number: E41D18)
- Hydroxocobalamin 1mg/ml, 30ml vial (lot number: E47025)
Administration of subpotent Hydroxocobalamin in infants, pregnant/breastfeeding women, and elderly populations are at risk for vitamin B12 deficiency and there is a reasonable probability they could experience adverse events including muscle weakness, neurological peripheral neuropathic numbness or pain, vision loss, and psychiatric disorders (depression, memory loss). Additionally, injectable compounded products, found to contain more or less drug product than the labeled strength or which reconstitute at a different rate than intended, may result in either too much or too little medication being administered. This could result in lower-than-expected effectiveness of the drug or unintended adverse side effects.
Olympia Pharmacy has not received any reports or concerns from patients relating to the safety of the recalled sterile compounded products, and no patients have reported any adverse events attributed to any of the recalled sterile compounded products.
The compounded products being recalled are typically prescribed by medical professionals for age management, erectile dysfunction, vitamin deficiencies, and for diagnostic imaging of the gallbladder.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympia-pharmacy-issues-voluntary-nationwide-recall-seven-compounded-products-due-being-out
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Mar 11, 2022
Issued at HKT 15:30
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