Why it was recalled
Failed Tablet/Capsule Specification; out of specification for tablet weight
Product description
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60
Lot numbers, UPCs & expiration codes
Lot # 3429066, exp 06/2018
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-1056-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 28,188 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1056-2017, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 77835
- Address
- 1090 Horsham Rd
- Code information
- Lot # 3429066, exp 06/2018
- Postal code
- 19454-1505
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1056-2017
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 28,188 bottles
- Termination date
- Jan 31, 2018
- Reason for recall
- Failed Tablet/Capsule Specification; out of specification for tablet weight
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 24, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 3, 2017