FDA Recalls Vitamin B Complex Injectable Due to Sterility Concerns
Oregon Compounding Centers is recalling Vitamin B Complex injectable vials due to quality control issues affecting sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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 an injectable product, 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 Vitamin B Complex (PRES) injectable, 100mg, 10 mL glass vials. The recall was initiated due to concerns regarding quality control procedures that present a potential risk to sterility assurance, as observed during a recent FDA inspection.
The affected product is distributed in Oregon and Washington. The specific lots subject to recall are Lot # 20140811@5 with a discard date of 10/16/2014, and Lot # 20140827@12 with a discard date of 11/25/2014. The total quantity involved is 490 mL.
Consumers and healthcare providers should check their inventory for these specific lot numbers and discard dates. If the product matches the recalled description, it should be returned to the pharmacy or the recalling firm for disposal or credit.
The recalled product
- Product
- VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
- Category
- Drug — Injectable
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 (3)
- Lot #: 20140811@5
- discard date 10/16/2014 Lot #: 20140827@12
- discard date 11/25/2014
Distribution
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.
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