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
FDA recall notice · announced August 17, 2016 · Teva
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Notes
Distribution: Nationwide
Lot/code information: Lot # 95113, exp 01/2017
Quantity: 8,052 bottles
Status: Terminated
Products in this recall event:
- 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 00 (D-1455-2016)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.