Drug product
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01
D-0014-2015
Product summary
- Event
- Event 69389
- Status
- Terminated
- Classification
- Class III
- Quantity
- 58,050 packets
- Official record key
drug-enforcement:D-0014-2015
Official wording
Reason: Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Code information: Lot # F12C01; Exp. 02/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent