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
Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lot numbers, UPCs & expiration codes
Lot #: 071515, Exp 10/15/2015
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-305-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 3, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- 1 dropper bottle
- 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-305-2016, 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 #: 071515, Exp 10/15/2015
- Postal code
- 61614-5828
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-305-2016
- Classification
- Class II
- Recalling firm
- Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Product quantity
- 1 dropper bottle
- 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
- Glycerin Opth Solution, 10 mL dropper bottles, 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