Wechem Hand Guard8/1000mL Bag, Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers
CGMP Deviations — Wechem Hand Guard8/1000mL Bag, Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA, 30013
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
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
CGMP Deviations
The recalled product
- Product
- Wechem Hand Guard8/1000mL Bag, Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA, 30013
- Manufacturer
- ABC Compounding Co., Inc.
- Category
- Drug — Drugs
- Affected units
- 5,800
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)
- 5800 bottles
Distribution
Distributed nationwide across the United States.
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