Apollo Care VANComycin Injection Recalled for Crystallization
Apollo Care is recalling VANComycin 1g in 0.9% Sodium Chloride injection due to crystallization that makes the product appear turbid. The affected lot was distributed in Missouri.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a compounded injectable drug with a quality defect (crystallization/turbidity). No illnesses or injuries are reported in the source text. The hazard is a potential loss of drug efficacy or sterility rather than an acute safety threat, consistent with a Moderate severity classification.
Plain-English summary
Apollo Care is recalling VANComycin 1g added to 250 mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, due to crystallization. The product appears turbid, indicating a potential quality defect.
The affected product is a compounded drug intended for hospital and office use only. The recall involves 225 bags from Lot #AC-016402 with an expiration date of 2/12/2022. The product was distributed in Missouri.
This is a compounded intravenous medication prepared by Apollo Care located at 3801 Mojave Court, Suite 101, Columbia, Missouri 65202. Healthcare facilities and providers who received this product should discontinue use and contact their supplier for instructions on return or disposal. Patients who may have received this product should consult their healthcare provider.
The recalled product
- Product
- VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25
- Manufacturer
- Apollo Care
- Category
- Drug — Compounded Injectable
- Affected units
- 225
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 #: AC-016402
- Exp 2/12/2022
Distribution
Distributed in 1 state:
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