Drug 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
D-1455-2016
Product summary
- Event
- Event 74502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,052 bottles
- Official record key
drug-enforcement:D-1455-2016
Official wording
Reason: Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Code information: Lot # 95113, exp 01/2017
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance