Class I — High risk. Reasonable probability of serious harm or death.
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.
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 Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Reason Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Reason Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged…
Reason Lack of Processing Controls
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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