Agency classClass IIOur severity:Severe FDA (Drugs)·D-0204-2015·Announced 2014-11-12

Recall of Injectable Methycobalamin Due to Sterility Assurance Concerns

Oregon Compounding Centers is recalling specific lots of injectable Methycobalamin due to quality control issues affecting sterility assurance identified during an FDA inspection.

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 the hazard involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or death if administered.

Plain-English summary

Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of Methycobalamin, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vials. The recall involves 119 0.3 mL vials and 106 1 mL vials distributed in Oregon and Washington.

The recall was initiated due to a lack of sterility assurance. FDA inspection observations regarding quality control procedures presented a potential risk to the sterility of the compounded sterile products. The affected lots have specific discard dates ranging from January 14, 2015, to March 11, 2015.

Consumers and healthcare providers should stop using the affected lots immediately. The specific lot numbers and discard dates are listed in the recall documentation. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product: METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Injectable Compounded Sterile Product
Hazard: sterility-assurance
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 (9)

Lot #: 20140718@2/0.3
discard date: 1/14/2015
Lot #: 20140808@4/0.3
discard date: 2/4/2015
Lot #: 20140902@36/1
discard date: 3/1/2015
Lot #: 20140902@37/0.3
Lot #: 20140912@22/1
discard date: 3/11/2015.

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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