D-1455-2016 Class II Terminated

Recalled by Teva North America — Horsham, PA

Recall Details

Product Type
Drugs
Report Date
August 17, 2016
Initiation Date
June 22, 2016
Termination Date
January 26, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,052 bottles

Product Description

Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16

Reason for Recall

Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.

Distribution Pattern

Nationwide

Code Information

Lot # 95113, exp 01/2017