Recalls / Class II
Class IID-1734-2019
Product
Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-04, UPC 3 11917 18247 6
- Brand name
- Maximum Strength Hydrocortisone Cream
- Generic name
- Hydrocortisone Cream
- Active ingredient
- Hydrocortisone
- Route
- Topical
- NDC
- 0363-0638
- FDA application
- M017
- Affected lot / code info
- Lot #56J17 EXP 07/2019
Why it was recalled
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recalling firm
- Firm
- US Pharmaceuticals Inc.
- Manufacturer
- Walgreens
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 681 Main St Ste 27, N/A, Belleville, New Jersey 07109-3471
Distribution
- Quantity
- 651 cases
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2019-07-11
- FDA classified
- 2019-08-13
- Posted by FDA
- 2019-08-21
- Terminated
- 2020-06-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1734-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.