Recalls / Class II
Class IID-0850-2022
Product
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-65
- Affected lot / code info
- Lot: 15644, Exp.: 05/31/2022
Why it was recalled
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Recalling firm
- Firm
- McKesson Corporation dba McKesson Drug Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4853 Crumpler Rd, N/A, Memphis, Tennessee 38141-8301
Distribution
- Quantity
- 55,440 tubes
- Distribution pattern
- Nationwide in the United States including Guam and the Northern Mariana Islands.
Timeline
- Recall initiated
- 2022-04-21
- FDA classified
- 2022-05-05
- Posted by FDA
- 2022-05-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0850-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.