The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1107-2015·Announced 2015-06-03

FDA Recalls Vitamin D3 Injectable Due to Sterility Concerns

Advanced Physician Solutions is recalling Vitamin D3 (Olive Oil) 50,000 Units/mL Injectable due to a lack of assurance of 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, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Vitamin D3 (Olive Oil) 30mL Vial 50,000 Units/mL Injectable. The product was manufactured by Advanced Physician Solutions, Inc., located in North Hollywood, California.

The recall was initiated because of a lack of assurance of sterility. The source text does not specify which lots are affected, the quantity of units recalled, or the specific distribution locations beyond the manufacturer's address.

Consumers and healthcare providers should stop using the product and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product
VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Manufacturer
Advanced Physician Solutions, Inc.
Category
Drug — Injectable
Hazard
Affected units
2

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 (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 recalled by Advanced Physician Solutions, Inc. 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 18 products in this recall →

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