Why it was recalled
Defective Container; leaking around the cap
Product description
Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA NDC 61958-0602-1 Gilead Sciences, Inc. Foster City, CA 94404.
Lot numbers, UPCs & expiration codes
FG Lot Number: HDNTD1 and HDNTD exp 30-Jun-15, KCMGD and KCMGD1 exp 31-Oct-15, KYGHA, KYGKA and KYGKK exp 30-Apr-16, MZVBA and MZTZA exp 31-Oct-16
Where it was sold
United States, Puerto Rico, Fiji.
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-0045-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 1, 2014
- FDA report date
- Nov 5, 2014
- Quantity
- 6,290 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Gilead Sciences, Inc.
Original FDA data
Every field from FDA enforcement report D-0045-2015, exactly as published.
Show all FDA fields
- City
- Foster City
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 69411
- Address
- 333 Lakeside Dr
- Code information
- FG Lot Number: HDNTD1 and HDNTD exp 30-Jun-15, KCMGD and KCMGD1 exp 31-Oct-15, KYGHA, KYGKA and KYGKK exp 30-Apr-16, MZVBA and MZTZA exp 31-Oct-16
- Postal code
- 94404-1147
- Report date
- Nov 5, 2014
- Product type
- Drugs
- Recall number
- D-0045-2015
- Classification
- Class II
- Recalling firm
- Gilead Sciences, Inc.
- Product quantity
- 6,290 bottles
- Termination date
- May 11, 2015
- Reason for recall
- Defective Container; leaking around the cap
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA NDC 61958-0602-1 Gilead Sciences, Inc. Foster City, CA 94404.
- Distribution pattern
- United States, Puerto Rico, Fiji.
- Recall initiation date
- Oct 1, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2014