Recalls / Class II
Class IID-0426-2019
Product
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03
- Brand name
- Hydrocortisone Cream Intensive Healing
- Generic name
- Hydrocortisone Cream
- Active ingredient
- Hydrocortisone
- Route
- Topical
- NDC
- 0363-0237
- FDA application
- M017
- Affected lot / code info
- Lot #: 36G17, 47G17, Exp. 5/2019; 84J17, Exp. 7/2019
Why it was recalled
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Recalling firm
- Firm
- US Pharmaceuticals Inc.
- Manufacturer
- Walgreens
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 681 Main St Ste 27, Belleville, New Jersey 07109-3471
Distribution
- Quantity
- 67848 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2018-12-07
- FDA classified
- 2019-02-04
- Posted by FDA
- 2019-02-13
- Terminated
- 2023-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0426-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.