Why it was recalled
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Product description
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.
Lot numbers, UPCs & expiration codes
Lots: (a) Lot # 35436769A, exp. date 05/2019; 35438389A, 35438390A, exp. date 01/2020; 35440838A, exp. date 10/2020; (b) 35437491A, 35443574B, exp. date 09/2021
Where it was sold
Nationwide in the USA and Puerto Rico
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-1205-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 12, 2019
- FDA report date
- Apr 24, 2019
- Quantity
- 171,488 150 mL and 80 mL bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1205-2019, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 82619
- Address
- 1090 Horsham Rd
- Code information
- Lots: (a) Lot # 35436769A, exp. date 05/2019; 35438389A, 35438390A, exp. date 01/2020; 35440838A, exp. date 10/2020; (b) 35437491A, 35443574B, exp. date 09/2021
- Postal code
- 19454-1505
- Report date
- Apr 24, 2019
- Product type
- Drugs
- Recall number
- D-1205-2019
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 171,488 150 mL and 80 mL bottles
- Termination date
- Jul 8, 2020
- Reason for recall
- Subpotent Product: assay results for Amoxicillin were below the specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Apr 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 18, 2019