If You Have Any of These 7 Medications, Stop Using Them Now, FDA Warns
THERE IS "REASONABLE PROBABILITY" THESE DRUGS COULD CAUSE ADVERSE AFFECTS.
Patients who take prescribed medicines depend on the label for accuracy. But in some cases, the label may not exactly match the contents of the drugs inside—and that can be a serious problem. Read on to find out about the latest drug recall resulting from multiple medications that don't meet specifications—and learn what to do if you have any of the affected drugs at home right now.
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Olympia Pharmacy is voluntarily recalling multiple lots of seven drugs found to be out of specification.
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Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD compounded injectables, already distributed to consumers. The company found these compounded products to be out of specification. Olympia announced the recall on Mar. 10, and the U.S. Food & Drug Administration (FDA) posted the recall notice on the same day.
There is "reasonable probability" these drugs could cause adverse affects.
According to the risk statement in the recall notice, administration of hydroxocobalamin that is not potent enough in infants, pregnant or 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 including depression and memory loss.
Further, injectable compounded products that were to contain more or less medication than the strength on the label, or which reconstitute at a different rate than intended, may cause either too much or too little drug to be administered. And this in turn could lead to less effectiveness or unintended negative side effects.
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The compounded drugs subject to the recall are used for a diverse range of applications.
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The drugs subject to the current recall are usually prescribed for a wide range of applications including erectile dysfunction, vitamin deficiencies, and for diagnostic imaging of the gallbladder.
Fortunately, Olympia Pharmacy has not received any reports or concerns from users about the safety of the recalled sterile compounded products, and no patients have reported any adverse events attributed to use so far.
Here's how to know if you have. any of the recalled drugs at home right now.
The recall notice specifies the 11 specific lot numbers (C41008; D24005; D24001; D41C19; D44026; F42104; E41F10; E41G10; E41C18; E41D18; E47025) associated with the seven different drugs named in the recall, a diverse array of products which all have best-use by dates through June 2022. These were distributed to patients and health clinics.
To check whether you have any of the affected drugs at home right now, read the lot number in the black strike zone of the label.
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Here's what to do if you have any of the medications subject to recall.
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Olympia Pharmacy is notifying its customers by mail and is arranging for return and replacement of all recalled compounded products. Patients and health clinics that have any of the listed compounded products subject to the recall are asked to stop using them right away and return them to Olympia Pharmacy.
If you have any questions regarding this recall, you can contact Olympia Pharmacy by phone at 407-250-4000 or email at [email protected] Monday through Friday from 9 a.m. to 6 p.m. EST.
You can also contact Tennessee Technical Coatings at 931-359-6666 or by email at [email protected] Monday through Thursday 8 a.m. through 5 p.m. CST. If you think you might have experienced any problems that may be related to using these drugs, contact your doctor or healthcare provider.
Adverse reactions or quality problems may be reported to the FDA's MedWatch Adverse Event Reporting program either by completing and submitting the form online, or by regular mail or fax.
To use either of those two methods, download this form (or call 800-332-1088 to request a reporting form), then complete it and return it to the address on the pre-addressed form, or submit it by fax to 800-FDA-0178.
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