UltraSure Anti-Perspirant & Deodorant
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.
Compare with the code on your package — it is the most precise check available.
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Skin Protectant with Lanolin Lanolin NDC 68599-6202 |
50 g/100g | Cream Topical |
McKesson Medical-Surgical Inc. | OTC |
| Skin Protectant with Lanolin Lanolin NDC 68599-6203 |
50 g/100g | Cream Topical |
McKesson | OTC |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Incorrect Product Formulation: product did not contain insulin as listed in the label.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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