busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area…
Reason Subpotent drug
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.
CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Subpotent drug
Reason Presence of foreign substance: identified as aluminum.
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
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