Why it was recalled
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
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
Lot numbers, UPCs & expiration codes
Lot # 95113, exp 01/2017
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1455-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 22, 2016
- FDA report date
- Aug 17, 2016
- Quantity
- 8,052 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva North America
Original FDA data
Every field from FDA enforcement report D-1455-2016, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 74502
- Address
- 425 Privet Rd
- Code information
- Lot # 95113, exp 01/2017
- Postal code
- 19044-1220
- Report date
- Aug 17, 2016
- Product type
- Drugs
- Recall number
- D-1455-2016
- Classification
- Class II
- Recalling firm
- Teva North America
- Product quantity
- 8,052 bottles
- Termination date
- Jan 26, 2017
- Reason for recall
- Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 22, 2016
- Initial firm notification
- Letter
- Center classification date
- Aug 9, 2016