Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution.
Educational materials to help empower your customers. Stericycle also will provide you with … A further list and descriptions of these risks, uncertainties and other factors can be found in the Company’s most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2019 as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. is missing and return defective devices for a replacement. Products We produce quality generic, specialty and biosimilar medicines; Our Portfolio. Teacher claimed she was insufficiently informed about child's allergy despite documentatio Subscribe for our weekly newsletter and never miss an important food allergy article! Resources and information to help prescribe, dispense and take medicine with confidence.By clicking Continue below you are leaving Mylan.com and going to a third-party site.If you think you may be impacted by this recall, it is very important that you first contact Stericycle at 877-650-3494. Copies of these filings are available online at Amneal Pharmaceuticals, which sells a generic epinephrine auto-injector similar to Mylan's flagship Epipen, has initiated a sweeping restructuring of its … Anyone who received one of the devices after Dec. 20, 2018, is urged to inspect it. Generic Products ; Specialty Products; Product Catalog; Quality; Drug Safety. Stericycle’s hours of operation are Monday-Friday 8 a.m.-10 p.m. Impax Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals LLC, is providing important safety information concerning its Epinephrine Injection, USP Auto-Injector 0.3 mg. Impax is writing to inform you that some Epinephrine Injection, USP Auto-Injector 0.3 mg devices may not contain the yellow “stop collar” component (see pictures below). The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto-Injector, and may be substituted for EpiPen Auto-Injector.Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall.Please check back here for any updates and additional information on the product return and replacement process.Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPenThe recall impacts certain lots of the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 877-835-5472, option 1 or email [email protected]. Such risks and uncertainties include, but are not limited to, risks related to the products and recall thereof described in this press release.
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When receiving an EpiPen or EpiPen Jr Auto-Injector and before you need to use the EpiPen or EpiPen Jr Auto-Injector, remove the auto-injector from the carrier tube and check the auto-injector to make sure the blue safety release is not raised (see Figure 1 in the Instructions for Use). Details about our brand-name and generic medicines. Follow AMRX. (For specific lot numbers, see list in this letter.)
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June 1, 2020 -- FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.
Patients may receive either EpiPen Auto-Injector or Mylan’s authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability.
If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal Pharmaceuticals, Inc. (the “Company”).
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