Teva North America recalls Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited…

Recall date

June 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1455-2016

FDA classification

Class II

Brand / firm

Teva North America

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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