Prescription and over-the-counter medications
Morton Grove Pharmaceuticals
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Grupo Asimex de Mexico SA de CV
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Lack of processing controls
Meitheal Pharmaceuticals
Failed Impurities/Degradation Specifications
Ebay Seller - John Nguyen
Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
Prescription Labs Inc
Lack of Assurance of Sterility
Superpotent Drug
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Rhodes Pharmaceuticals, L.P.
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Grupo Asimex de Mexico SA de CV
CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Subpotent
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.