DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling DermaCol 100 Collagen Powder (1 Gram, Model Number 00300E) due to facility temperature excursions that occurred from June through August 2021 prior to product delivery. Products with lot codes received between June 1, 2021 and September 30, 2021 may have been exposed to higher temperatures that could have impacted the product's effectiveness. However, the manufacturer states this device with this specific storage temperature deviation is not likely to cause adverse health consequences. The affected products were distributed nationwide in a quantity of 25 units with GTINs 00714196391346, 01714196300019, and 00714196300010.
The recall record does not specify a remedy or instructions for what affected consumers should do with their product.
Written by software from the official notice below. Not reviewed by a lawyer.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Reason for recall: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences. Distribution: US Nationwide distribution. Quantity: 25 Lot/code info: GTIN: 00714196391346; 01714196300019; 00714196300010
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.