Why it was recalled
Defective Container: Tamper evident ring failures discovered on some bottles.
Product description
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1
Lot numbers, UPCs & expiration codes
Lot # A358502; Exp 01/15
Where it was sold
Nationwide, Italy and Republic of South Korea
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-1356-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 29, 2014
- FDA report date
- Jun 11, 2014
- Quantity
- 4,155 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1356-2014, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 67532
- Address
- 235 East 42nd Street
- Code information
- Lot # A358502; Exp 01/15
- Postal code
- 10017-5703
- Report date
- Jun 11, 2014
- Product type
- Drugs
- Recall number
- D-1356-2014
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 4,155 bottles
- Termination date
- Mar 14, 2017
- Reason for recall
- Defective Container: Tamper evident ring failures discovered on some bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1
- Distribution pattern
- Nationwide, Italy and Republic of South Korea
- Recall initiation date
- Jan 29, 2014
- Initial firm notification
- Letter
- Center classification date
- May 30, 2014