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
Reported: August 17, 2016 Initiated: June 22, 2016 #D-1455-2016
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.
Details
- Recalling Firm
- Teva North America
- Units Affected
- 8,052 bottles
- Distribution
- Nationwide
- Location
- Horsham, PA
Frequently Asked Questions
What product 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. Recalled by Teva North America. Units affected: 8,052 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 17, 2016. Severity: Moderate. Recall number: D-1455-2016.
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