Ranier's Compounding Laboratory Recalls Vitamin D3 Injection Due to Sterility Concerns
Ranier's Compounding Laboratory is recalling Vitamin D3 Injection, 50,000 IU/mL, 4 mL vials, because practices at the firm may call into question the sterility of the product.
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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are classified as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
Ranier's Compounding Laboratory is recalling Vitamin D3 Injection, 50,000 IU/mL, 4 mL vials, which are prescription-only. The recall is being conducted because practices at the firm may call into question the sterility of products intended to be sterile.
The affected product was distributed within the state of Pennsylvania. The recall covers all lots within expiry. The specific quantity recalled is 2 vials.
Consumers who have this product should contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, which means use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
- Manufacturer
- Ranier's Compounding Laboratory
- Category
- Drug — Injectable
- Affected units
- 2
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 within expiry
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 15 recalled by Ranier's Compounding Laboratory 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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