Why it was recalled
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Product description
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
Lot numbers, UPCs & expiration codes
Lot #s: 1164898, EXP 10/18; 1164904, 1164909, EXP 11/18; 1211396, EXP 07/19; 1230808, 1231127, EXP 01/20
Where it was sold
Nationwide in the USA and Puerto Rico
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-0909-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 5, 2018
- FDA report date
- Jul 18, 2018
- Quantity
- 27,803 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0909-2018, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 80437
- Address
- 1090 Horsham Rd
- Code information
- Lot #s: 1164898, EXP 10/18; 1164904, 1164909, EXP 11/18; 1211396, EXP 07/19; 1230808, 1231127, EXP 01/20
- Postal code
- 19454-1505
- Report date
- Jul 18, 2018
- Product type
- Drugs
- Recall number
- D-0909-2018
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 27,803 bottles
- Termination date
- Apr 3, 2019
- Reason for recall
- Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jul 5, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 6, 2018