FDA recall D-1455-2016

Product

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

Nationwide

Key facts

Status

Terminated

Initiation date

2016-06-22

Report date

2016-08-17

Termination date

2017-01-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1455-2016