Why it was recalled
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Product description
Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lot numbers, UPCs & expiration codes
Lot #: 062515, Exp 09/25/2015; and 070615, Exp 10/06/2015
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-303-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 3, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- 2 ointment tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Original FDA data
Every field from FDA enforcement report D-303-2016, exactly as published.
Show all FDA fields
- City
- Peoria
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 72241
- Address
- 4625 N University St
- Code information
- Lot #: 062515, Exp 09/25/2015; and 070615, Exp 10/06/2015
- Postal code
- 61614-5828
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-303-2016
- Classification
- Class II
- Recalling firm
- Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Product quantity
- 2 ointment tubes
- Termination date
- Dec 29, 2017
- Reason for recall
- Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 3, 2015
- Initial firm notification
- Letter
- Center classification date
- Nov 17, 2015