Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot # 95113, exp 01/2017
Why it was recalled
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Recalling firm
- Firm
- Teva North America
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 8,052 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-06-22
- FDA classified
- 2016-08-09
- Posted by FDA
- 2016-08-17
- Terminated
- 2017-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1455-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.