The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1090-2015·Announced 2015-06-03

Advanced Physician Solutions Recalls Cyanocobalamin Injectable Due to Sterility Concerns

Advanced Physician Solutions is recalling 77 vials of Cyanocobalamin injectable nationwide 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

Advanced Physician Solutions, Inc. is recalling 77 vials of Cyanocobalamin (Paraben Water) 2000mcg/ml Injectable. The product is available in 10ml and 30ml vials and was distributed nationwide. The recall is being conducted because of a lack of assurance of sterility.

The recall includes all lots of the product. The source text does not specify specific lot numbers, expiration dates, or the exact number of units distributed beyond the 77 vials mentioned in the structured data.

Consumers and healthcare providers should stop using the recalled product and contact Advanced Physician Solutions, Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Manufacturer
Advanced Physician Solutions, Inc.
Category
Drug — Injectable
Hazard
Affected units
77

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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