Metro IV FDA Alerts

Metronidazole Tablets, 250mg: Recall - Underweight Tablets

[Posted 01/06/2011]

ISSUE: Teva Pharmaceuticals and FDA notified healthcare professionals and the public of a recall of Metronidazole Tablets USP, 250mg, lot #312566, expiration date 05/2012. This product lot is being recalled due to the presence of underweight tablets. Underweight tablets may not contain the full amount of active ingredient within a single tablet, and a consumer may not receive the prescribed dose. This may cause the infection the drug was intended to treat to worsen or recur, which could be life-threatening when treating severe infections.

BACKGROUND: Metronidazole is indicated for the treatment of symptomatic and asymptomatic trichomoniasis, and treatment of asymptomatic consorts, amebiasis and a variety of anaerobic bacterial infections. The affected Metronidazole lot is packaged in 250 count bottles and was distributed nationwide to wholesalers and retailers.

RECOMMENDATION: Consumers who have lot 312566 in their possession are instructed to cease using the product and return it to their pharmacy.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Intravenous Medications Manufactured by Claris: Recall due to contamination of products

Metronidazole, Ciprofloxacin and Ondansetron sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels.

 FDA notified healthcare professionals not to use the intravenous medications, metronidazole, ciprofloxacin and ondansetron manufactured by Claris Lifesciences due to contamination. These products were all manufactured on the same manufacturing line and sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. The FDA received reports of floating matter in intravenous bags of metronidazole and ondansetron. Foreign matter should not be present in a sterile injectable product. Healthcare professionals should not use these products and should immediately remove them from their pharmacy inventories. Claris is initiating a recall of all lots of these products. FDA is further investigating the situation and will notify the public when new information becomes available.

Please review the linked Public Health Alert for a list of the affected and recalled products.

[05/29/2010 - Public Health Alert - FDA]

[06/02/2010 - Firm Press Release - Claris Lifesciences]

Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility

Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL manufactured by Claris Lifesciences and distributed by Sagent due to the discovery of non-sterility in two lots of metronidazole injection. Non-sterility of an antimicrobial administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Sagent is not aware of any adverse patient events resulting from this product and is continuing its diligent investigation of the situation.

The lot numbers being recalled are: A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, A090775, A090776, A090968, A091014, A000013, A000016 and A000019, which were distributed to hospitals, wholesalers and distributors nationwide from February through May 2010. Metronidazole injection, USP is an intravenous antimicrobial product used to treat infections and is supplied in a single dose plastic container.

[05/17/2010 - Press Release - Sagent Pharmaceuticals]