Agency classClass IIOur severity:Severe FDA (Drugs)·D-0176-2015·Announced 2014-11-12

FDA Recalls Injectable Ascorbic Acid Vials Due to Sterility Concerns

Oregon Compounding Centers is recalling injectable ascorbic acid vials because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.

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 and involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or death from infection.

Plain-English summary

Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vials. The recall involves 7,900 mL of product distributed in Oregon and Washington.

The recall was initiated due to a lack of sterility assurance. During a recent FDA inspection, quality control procedures were observed that present a potential risk to the sterility assurance of all lots of sterile products compounded by the pharmacy that are not expired. The agency has classified this recall as Class II.

Consumers and healthcare providers should check their inventory for the following lot numbers and discard dates: Lot # 20140827@34 (discard date 10/26/2014), Lot # 20140909@22 (discard date 11/8/2014), and Lot # 20140912@2 (discard date 11/11/2014). If you have these products, do not use them and contact the recalling firm for instructions on return or disposal.

The recalled product

Product: ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Injectable Compounded Medication
Hazard: lack-of-sterility
infection-risk

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 (6)

Lot #: 20140827@34
discard date: 10/26/2014
Lot #: 20140909@22
discard dae: 11/8/2014
Lot #: 20140912@2
discard date: 11/11/2014.

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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 56 products in this recall →

Same manufacturer · Oregon Compounding Centers, Inc. dba Creative Compounds

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Same hazard · lack of sterility