CVS Health Baby Eczema Moisturizing Cream Recalled for Microbial Contamination
Sigan Industries is recalling CVS Health Baby Eczema Moisturizing Cream due to microbial contamination. The product failed to meet total plate count specifications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe; while specific injury reports are not detailed in the snippet, the agency classification of Class II for a drug product with microbial contamination aligns with the Severe tier (4) as it is not a Class I (Critical) but represents a significant risk.
Plain-English summary
Sigan Industries Inc. is recalling CVS Health Baby Eczema Moisturizing Cream (colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes. The recall involves 19,608 tubes with lot number 17-01319 and an expiration date of 01/19. The product is distributed by CVS Pharmacy Inc. in Woonsocket, RI, and was distributed in California.
The recall was initiated because the product was found to be out of specification for Total Plate Count, indicating microbial contamination of the non-sterile product. The FDA has classified this recall as Class II.
Consumers who have purchased this specific lot of the product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes, OTC, Distributed by CVS Pharmacy Inc., Woonsocket, RI --- UPC 050428568033
- Manufacturer
- Sigan Industries Inc.
- Category
- Drug — Topical OTC
- Hazard
- Affected units
- 19,608
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 number 17-01319
- exp 01/19
Distribution
Distributed in 1 state:
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