Why it was recalled
Failed Impurity/Degradation Specification; 12-month stability time point
Product description
Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.
Lot numbers, UPCs & expiration codes
Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
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-1484-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 20, 2014
- FDA report date
- Sep 3, 2014
- Quantity
- 25,776 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novel Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1484-2014, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68722
- Address
- 400 Campus Dr
- Code information
- Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
- Postal code
- 08873-1145
- Report date
- Sep 3, 2014
- Product type
- Drugs
- Recall number
- D-1484-2014
- Classification
- Class III
- Recalling firm
- Novel Laboratories, Inc.
- Product quantity
- 25,776 containers
- Termination date
- Jun 29, 2015
- Reason for recall
- Failed Impurity/Degradation Specification; 12-month stability time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 20, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 22, 2014