Why it was recalled
Chemical Contamination
Product description
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
Lot numbers, UPCs & expiration codes
Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17
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-0653-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 22, 2017
- FDA report date
- Apr 19, 2017
- Quantity
- 7,656 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novel Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0653-2017, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76231
- Address
- 390 & 400 Campus Drive
- Code information
- Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17
- Postal code
- 08873-1145
- Report date
- Apr 19, 2017
- Product type
- Drugs
- Recall number
- D-0653-2017
- Classification
- Class III
- Recalling firm
- Novel Laboratories, Inc.
- Product quantity
- 7,656 bottles
- Termination date
- Aug 19, 2019
- Reason for recall
- Chemical Contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 11, 2017