Why it was recalled
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Product description
CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lot numbers, UPCs & expiration codes
Lot #:01082016:75@3, Exp.07/06/2016; Lot #:01282016:72@10, Exp. 07/27/2016; Lot #: 02012016:74@35, Exp. 07/31/2016; Lot #:02102016:40@16, Exp.08/09/2016; Lot #: 02242016:73@41, Exp. 08/23/2016; Lot #: 03102016:64@53, Exp.09/07/2016; Lot #:04052016:70@16 Exp. 10/02/2016; Lot #: 04222016:85@37, Exp.10/22/2016.
Where it was sold
NV
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-1026-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 17, 2016
- FDA report date
- Jun 15, 2016
- Quantity
- 916 total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Well Care Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-1026-2016, exactly as published.
Show all FDA fields
- City
- Las Vegas
- State
- NV
- Status
- Terminated
- Country
- United States
- Event ID
- 74187
- Address
- 3430 E Tropicana Ave Ste 9
- Code information
- Lot #:01082016:75@3, Exp.07/06/2016; Lot #:01282016:72@10, Exp. 07/27/2016; Lot #: 02012016:74@35, Exp. 07/31/2016; Lot #:02102016:40@16, Exp.08/09/2016; Lot #: 02242016:73@41, Exp. 08/23/2016; Lot #: 03102016:64@53, Exp.09/07/2016; Lot #:04052016:70@16 Exp. 10/02/2016; Lot #: 04222016:85@37, Exp.10/22/2016.
- Postal code
- 89121-7345
- Report date
- Jun 15, 2016
- Product type
- Drugs
- Recall number
- D-1026-2016
- Classification
- Class II
- Recalling firm
- Well Care Compounding Pharmacy
- Product quantity
- 916 total
- Termination date
- Jan 13, 2017
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Distribution pattern
- NV
- Recall initiation date
- May 17, 2016
- Initial firm notification
- Press Release
- Center classification date
- Jun 9, 2016