FDA recall D-247-2013

Teva Pharmaceuticals USA, Inc. · Class II · drug

Product

Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960.

Reason for recall

Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-02-26
Report date: 2013-04-17
Termination date: 2014-01-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-247-2013