Milbar Recalls Subpotent Coal Tar Shampoo for Hair and Body
Milbar Laboratories is voluntarily recalling 952 bottles of T Shampoo For Hair and Body because the product is subpotent.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences or death.
Plain-English summary
Milbar Laboratories, Inc. is voluntarily recalling 952 bottles of T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles. The recall was initiated on May 4, 2018, and was classified as Class III by the FDA. The reason for the recall is that the product is subpotent, meaning it contains less than the labeled amount of the active ingredient.
The affected product is identified by Lot # MT390-8 with an expiration date of 12/01/2020, and Lot # GU925-4 with an expiration date of 07/05/2020. The product was distributed to physicians and through internet sales throughout the United States, as well as in Hong Kong, Panama, the UK, China, Jordan, Qatar, Kuwait, and Central America.
Consumers who have this product should stop using it and contact Milbar Laboratories, Inc. for further instructions. The recall status is currently terminated.
The recalled product
- Product
- T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
- Manufacturer
- Milbar Laboratories, Inc.
- Category
- Drug — Topical Dermatologic
- Hazard
- Affected units
- 952
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)
- Lot # MT390-8
- expiration date 12/01/2020 GU925-4
- expiration date 07/05/2020
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Milbar Laboratories, Inc. under a single FDA (Drugs) 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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