Why it was recalled
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # F12C01; Exp. 02/15
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-0014-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 18, 2014
- FDA report date
- Oct 15, 2014
- Quantity
- 58,050 packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostic Inc
Original FDA data
Every field from FDA enforcement report D-0014-2015, exactly as published.
Show all FDA fields
- City
- Monroe Township
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69389
- Address
- 259 Prospect Plains Road
- Address (line 2)
- Building H
- Code information
- Lot # F12C01; Exp. 02/15
- Postal code
- 08831
- Report date
- Oct 15, 2014
- Product type
- Drugs
- Recall number
- D-0014-2015
- Classification
- Class III
- Recalling firm
- Bracco Diagnostic Inc
- Product quantity
- 58,050 packets
- Termination date
- Jun 30, 2015
- Reason for recall
- Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 18, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2014