Recalls / Class III

Class IIID-0431-2017

Product

Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

Affected lot / code info

Lot # 34027040A; Exp 10/17

Why it was recalled

Failed Dissolution Specifications

Recalling firm

Firm

Teva Pharmaceuticals USA

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1090 Horsham Rd, North Wales, Pennsylvania 19454-1505

Distribution

Quantity

6,800 cartons

Distribution pattern

Nationwide in the USA and Puerto Rico

Timeline

Recall initiated

2016-12-01

FDA classified

2017-01-13

Posted by FDA

2017-01-25

Terminated

2017-06-29

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0431-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.