Drug product
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60
D-1056-2017
Product summary
- Event
- Event 77835
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28,188 bottles
- Official record key
drug-enforcement:D-1056-2017
Official wording
Reason: Failed Tablet/Capsule Specification; out of specification for tablet weight
Code information: Lot # 3429066, exp 06/2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification