D-1455-2016 Class II Terminated
FDA drug recall D-1455-2016 was initiated by Teva North America on June 22, 2016 and is designated Class II. Reason for recall: Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material. The recall status is terminated (terminated January 26, 2017). Affected quantity: 8,052 bottles.
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