Milbar Recalls DCL T Shampoo for GMP Deviations
Milbar Laboratories is voluntarily recalling 1,225 bottles of DCL T Shampoo due to Good Manufacturing Practice (GMP) deviations.
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
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: The recall is classified as FDA Class II and is voluntary, with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Milbar Laboratories, Inc. is voluntarily recalling 1,225 bottles of DCL T Shampoo for Hair and Body (Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/10.1 fl.oz. The recall was initiated on October 9, 2020, and is classified as Class II by the FDA. The specific reason for the recall is Good Manufacturing Practice (GMP) deviations.
The affected product is identified by Lot # DW913-9 and has an expiration date of April 2022. The product was distributed throughout the United States, including Puerto Rico, and internationally. The recall was initiated by the firm and was terminated on January 4, 2023.
Consumers who have this product should stop using it and contact the recalling firm for further instructions. The recall is voluntary and was initiated by the firm.
The recalled product
- Product
- DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/ 10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 3574865069947
- Manufacturer
- Milbar Laboratories, Inc.
- Category
- Drug — Topical Dermatologic
- Hazard
- Affected units
- 1,225
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 (2)
- Lot #: DW913-9
- Exp. Date Apr-22
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 14 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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