The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1026-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls Otic Solution Due to Sterility Concerns

Well Care Compounding Pharmacy is recalling specific lots of Clotrimazole 1%/Betamethasone Dipropionate 0.05% Otic Solution because FDA inspections found GMP violations that may affect sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant harm (such as sterility issues in a medical product) align with a score of 4 (Severe), as they are not Class I but involve risks beyond minor labeling errors.

Plain-English summary

Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 916 units of Clotrimazole 1%/Betamethasone Dipropionate 0.05% Otic Solution, 15mL dropper, prescription only. The recall involves eight specific lots with expiration dates ranging from July 2016 to October 2016. The product was distributed in Nevada.

The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer
Well Care Compounding Pharmacy
Category
Drug — Compounded Prescription
Hazard
Affected units
916

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • 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.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Well Care Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 51 products in this recall →

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