‘Lots’ Tagged Posts

Expiration Dates Prolonged for Sure A lot of Generic Adrenaclick

Expiration date for specific lots will be increased from 18 months to 20 months The expiration dates for certain lots of epinephrine injection, USP au...

 
Expiration date for specific lots will be increased from 18 months to 20 months

Expiration date for specific lots will be increased from 18 months to 20 months

The expiration dates for certain lots of epinephrine injection, USP auto-injector 0.15mg and 0.3mg (Impax Laboratories), the authorized generic of Adrenaclick, have been extended by 2 months after the Company coordinated with the Food and Drug Administration (FDA) to address the ongoing drug shortage.

Epinephrine auto-injectors are indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis. The expiration dates of these lots have been increased from 18 months to 20 months; the full list can be viewed here.  “This announcement is made after a comprehensive evaluation of data to enable the extension of the expiration date on specific lots,” said Joseph Greer, SVP, Global Quality Management, in a press release. 

FDA Extends Expiration Date for Sure Plenty of EpiPen

 
The FDA emphasized that these products should continue to be stored as directed on the label to ensure patient safety

The FDA emphasized that these products should continue to be stored as directed on the label to ensure patient safety

The Food and Drug Administration (FDA) has extended the expiration date of certain lots of Mylan’s EpiPen (epinephrine) Auto-Injector 0.3mg by 4 months past the labeled date. 

This date modification beyond the approved 20-month shelf life was based an FDA review of product stability data submitted by Mylan. Several factors contributed to the product’s limited availability in certain areas of the US, including regional supply disruptions and manufacturer issues. Specifically, Mylan cited intermittent supply constraints due to manufacturing delays from their partner, Meridian Medical Technologies, a subsidiary of Pfizer. Continual supply from Meridian is still ongoing and Mylan is expediting shipment to wholesalers upon receipt. Meridian also manufactures EpiPen Jr 0.15mg Auto-Injectors and the authorized generic versions of these strengths. 

The full list of EpiPen Auto-Injectors and Epinephrine Injection, USP Auto-Injectors 0.3mg with extended expiration dates can be found here. Patients with product from these batch numbers will be able to use them through the new use dates provided.

“We’ve completed the necessary reviews of the data to extend the expiration date by four months for specific lots of EpiPen that are expired or close to expiring. We’re hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

Dr Reddy's recalls five lots of Ranitidine tablets from US markets

 

Dr Reddy's recalls five lots of Ranitidine tablets from US markets
Dr Reddy's Laboratories has begun recalling five lots of its Ranitidine tablets, an anti-ulcer drug available over the counter, on account of microbial contamination. The details pertaining to this were released by the US Food and Drug Administration …
Read more on Business Today


Pharmalot, Pharmalittle: We're Reading About Actavis, Tax Inversions and Lots

 

Pharmalot, Pharmalittle: We're Reading About Actavis, Tax Inversions and Lots
The combination includes Dnebivolol and valsartan. A new poll shows strong support for congressional action to keep American companies – a list that includes many drug and device makers – from moving overseas for tax reasons, according to The Wall …
Read more on Wall Street Journal (blog)


Why am I hoarse and have lots of phlegm? No cold symptoms.?

 

Question by Jasmine: Why am I hoarse and have lots of phlegm? No cold symptoms.?
I’m on Azmacort and Albuterol when needed. Could this be the cause? Is there more to wory about?

Best answer:

Answer by ACEY
sounds like a sinus infection/and or alergy causing drainedge to your throat and making you hoarse.just my oppinion.my doctor just put me on a 5 day antibiotic treatment and a 6 day treatment of methyiprednisolone pills for the same thing.

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