Recalls / Class II
Class IID-309-2016
Product
HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Affected lot / code info
- Lot #: 081015, Exp 09/10/2015
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.
Recalling firm
- Firm
- Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4625 N University St, N/A, Peoria, Illinois 61614-5828
Distribution
- Quantity
- 1 vial
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-09-03
- FDA classified
- 2015-11-17
- Posted by FDA
- 2015-11-25
- Terminated
- 2017-12-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-309-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.