Collagen Powder Recalled Due to Temperature Exposure During Shipment
DermaCol 100 Collagen Powder was exposed to higher temperatures during storage from June to August 2021. The product's effectiveness may have been impacted, though the FDA determined no adverse health consequences are likely.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: FDA Class III device recall. The source explicitly states no adverse health consequences are likely from the temperature exposure. This is a precautionary recall due to storage conditions that may have affected product effectiveness.
Plain-English summary
DermaCol 100 Collagen Powder (1 gram packages, Model 00300E, manufactured by Mckesson Medical-Surgical Inc.) has been recalled due to facility temperature excursions that occurred from June 2021 through August 2021.
The affected product was exposed to higher than appropriate temperatures prior to delivery. This exposure may have impacted the product's effectiveness. All collagen powder lots received between June 1, 2021, and September 30, 2021, are affected by this recall.
The product was distributed nationwide throughout the United States. Consumers and healthcare providers who received this product during the specified timeframe should contact their supplier or the manufacturer. According to the FDA, this specific storage temperature deviation is not likely to cause adverse health consequences.
The recalled product
- Product
- DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device
- Affected units
- 25
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)
- GTIN: 00714196391346
- 01714196300019
- 00714196300010
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) 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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