FDA Class I recall of Blue Bull Extreme Male Enhancement Supplement by Pure Vitamins and Natural Supplements, LLC for undeclared sildenafil; distributed in New Jersey.
MEI YU CHENG DA TRADING INC recalls 29 cases of DADI NONGFU dried salt chili vegetables distributed in NY, PA, and FL due to banned cyclamate sweetener in a Class III recall.
Beckman Coulter recalls 3 boxes of MicroScan Neg Multidrug Resistant MIC test panels distributed to Poland due to manufacturing defects that may cause incorrect in vitro diagnostic results.
Spacelabs Healthcare recalls 1,790 multi-parameter command modules (Model 91496) due to circuit board defects that may cause inaccurate cardiac output measurements and delayed patient care.
Molded Products Inc. voluntarily recalls 26,900 units of MPC-130 See Luer Cap Set nationwide due to threaded sleeve detachment risk, classified as Class II medical device recall.
Brahms GmbH recalls Class II diagnostic test catalog 859075N due to out-of-range quality control values that may produce falsely elevated results if not properly troubleshot per instructions.
Teva Pharmaceuticals recalls 8,376 packages of Isotretinoin Capsules due to superpotent and subpotent batches in Florida, Ohio, Puerto Rico, and Mississippi.
FDA determines BILTRICIDE (praziquantel) 600mg oral tablets were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions meeting regulatory requirements.
FDA is withdrawing approval of GlaxoSmithKline's Wellcovorin (leucovorin calcium) tablets in 5 mg and 25 mg strengths due to the applicant's request following market discontinuation.
FDA seeks 60-day public comment on information collection requirements for premarket approval of medical devices under the Paperwork Reduction Act.
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