Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to … [Read more...]
INDIAN MANUFACTURING FACILITIES CONTINUE TO RECEIVE FDA REGULATORY ACTIONS
HOSPIRA'S IRUNGATTUKOTTAI FACILITY RECEIVES WARNING LETTER (052813) Recently Ranbaxy settled a $500 million lawsuit with the Dept. of Justice for selling improperly manufactured and tested drugs (see previous Blogs). More recently, Maharashtra-based Wockhardt received an Import ban (see previous Blogs to learn of what other Indian based … [Read more...]
“FDA’S CONTRIBUTION TO THE DRUG SHORTAGE CRISIS” — A HOUSE OF REPRESENTATIVES STAFF REPORT (6/15/12)
The U.S. House of Representatives Committee on Oversight and Government Reform recently published a 21 page staff report document that was highly critical of the FDA. Several of you had requested information regarding this report since you were interesting in reading the report that caused the FDA response. Enclosed below are several of the key … [Read more...]
FDA COMMENTS ON ITS ACTIONS INAPPROPRIATELY RESULTING IN SHUTDOWN OF MANUFACTURING FACILITIES (JULY 2012)
FDA recently commented on the report entitled “FDA’s Contribution to the Drug Shortage Crisis” for the Honorable Elijah E. Cummings. Within this letter from Jeanne Ireland, Assistant Commissioner for Legislation, she lays out the FDA’s response to specific questions that Mr. Cummings asks about Drug Shortages and whether the FDA contributed to them. His letter includes: “The … [Read more...]
HOSPIRA – WHEN IS A DRUG RECALL AN ALERT
 FDA RECOMMENDS ALERT TO AVOID DRUG SHORTAGES In a previous Blog (May 24, 2012) the issue of Warning Letters and how the FDA now on a routine basis is asking their Clients to advise them if the Warning Letter and its consequences will result in shortages was discussed. In this Blog, the FDA is using “Risk Management†… [Read more...]
