Recalls / Class II
Class IID-1056-2017
Product
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60
- Brand name
- Famotidine
- Generic name
- Famotidine
- Active ingredient
- Famotidine
- Route
- Oral
- NDCs
- 0172-5728, 0172-5729
- FDA application
- ANDA075511
- Affected lot / code info
- Lot # 3429066, exp 06/2018
Why it was recalled
Failed Tablet/Capsule Specification; out of specification for tablet weight
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 28,188 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-07-24
- FDA classified
- 2017-08-03
- Posted by FDA
- 2017-08-09
- Terminated
- 2018-01-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1056-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.