Agency classClass IIOur severity:Severe FDA (Drugs)·D-1025-2013·Announced 2013-09-18

Park Compounding Recalls Methylcobalamin Injection Due to Sterility Concerns

South Coast Specialty Compounding is recalling Methylcobalamin Injection 5 mg/mL vials due to a lack of assurance of sterility. The affected products were distributed in California and Indiana.

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 an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

South Coast Specialty Compounding, Inc. is recalling Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vials. The recall is being conducted due to a lack of assurance of sterility for the product.

The affected product is identified as Lot #06132013@1 with an expiration date of 12/10/2013. A total of 297 vials were distributed to locations in California and Indiana. The recall notice also references Park Compounding and other injectable products, but the specific product details provided pertain to the Methylcobalamin Injection.

Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product: Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
Manufacturer: South Coast Specialty Compounding, Inc.
Category: Drug — Injectable Medication
Hazard: sterility
infection
Affected units: 297

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 (2)

Lot #06132013@1
Exp 12/10/2013

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 3 recalled by South Coast Specialty Compounding, 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 3 products in this recall →

Same manufacturer · South Coast Specialty Compounding, Inc.

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Same hazard · sterility