Why it was recalled
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Product description
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
Lot numbers, UPCs & expiration codes
Lot A060644, May 2018
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-0605-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 2, 2018
- FDA report date
- Apr 4, 2018
- Quantity
- 1277 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Renaissance Lakewood, LLC
Original FDA data
Every field from FDA enforcement report D-0605-2018, exactly as published.
Show all FDA fields
- City
- Lakewood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79310
- Address
- 1200 Paco Way
- Code information
- Lot A060644, May 2018
- Postal code
- 08701-5938
- Report date
- Apr 4, 2018
- Product type
- Drugs
- Recall number
- D-0605-2018
- Classification
- Class III
- Recalling firm
- Renaissance Lakewood, LLC
- Product quantity
- 1277 bags
- Termination date
- Apr 10, 2020
- Reason for recall
- Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 23, 2018