Why it was recalled
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Product description
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.
Lot numbers, UPCs & expiration codes
Lot #: NC082768, Exp 12/23/2014
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-0293-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2014
- FDA report date
- Dec 17, 2014
- Quantity
- 19,152 Containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-0293-2015, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 68171
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: NC082768, Exp 12/23/2014
- Postal code
- 60015-4625
- Report date
- Dec 17, 2014
- Product type
- Drugs
- Recall number
- D-0293-2015
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 19,152 Containers
- Termination date
- Jun 16, 2015
- Reason for recall
- Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 24, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 10, 2014