Class III · Low risk Ongoing
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area…
Reason Subpotent drug
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
What was recalled
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
- Recalling firm
- Boiron Inc.
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0803-2018
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.
Other Iron recalls
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Class II · Moderate risk Ongoing
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia…
Reason Presence of foreign substance: identified as aluminum.
Class II · Moderate risk Ongoing
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor…
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous…
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For…
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
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