Clotrimazole 1%/ Betamethasone Dipropionate 0.05% Otic recall: Sterility Concern
CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Why was Clotrimazole 1%/ Betamethasone Dipropionate 0.05% Otic recalled?
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Recalling firm
- Well Care Compounding Pharmacy
- Quantity
- 916 total
- Distribution
- NV
- Recall date
- June 15, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)