Key Takeaway

VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. by Pharmacy Innovations was recalled on December 22, 2022. The hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

FDA Drug Class II Terminated

VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Recalled: December 22, 2022 ~N/A units affected D-0242-2023

Description

VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Hazard / Reason

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Drugs

Company Information

Pharmacy Innovations

Erie, PA, United States

View all 59 recalls by Pharmacy Innovations →

Distribution

Nationwide in the USA

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.