US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 22, 2016 (10 years ago)

Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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

Recalling firm
Teva North America
NDC code
0093-0661-16
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1455-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Albuterol recalls

See all