Adverse Events and Recalls

Baxter International recalls dextrose injection and four sodium chloride injections.

Agency issues precautionary recall due to manufacturing fault.

Agency issues precautionary recall due to manufacturing fault.

AstraZeneca, Bristol-Myers Squibb recall certain lots of of their antidiabetes drug Bydureon (eventide) due to manufacturing records that batches may contain underfilled vials.

ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.

Third compounding pharmacy recalls products due to FDA inspection.

The New Jersey-licensed specialty pharmacy recalls magnesium sulfate products and halts all production operations.

Mylan Inc. has issued a recall of three lots of the painkiller tablets, hydrocodone bitartrate and acetaminophen, USP 10 mg/500 mg, due to the potential risk that these lots (lots 3037841, 3040859 and 3042573) may exceed the potency stated on the label.

Bristol-Myers Squibb has initiated a voluntary recall of 10 lots of BiCNU (carmustine for injection) previously manufactured by Ben Venue Laboratories, a former, third-party contract manufacturer for the company, to the user level.

The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals' San Diego site.

Twelve lessons of what to do and what not to do to avoid quality problems.

ImClone Systems, Inc. (Branchburg, NJ), and Bristol-Myers Squibb (BMS, New York, NY) voluntarily recalled 13 lots of their cancer drug Erbitux (cetuximab) after a report from a doctor?s office about a leaking cap on a vial of the biologic.