Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only,
Summary
The FDA issued a Class II for Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed a by McKesson Corporation dba McKesson Drug Company. Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability stu.
Details
Source
Drug Recall
External ID
D-0850-2022
Action Date
2022-05-11
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot: 15644, Exp.: 05/31/2022
Quantity Affected: 55,440 tubes
Reason for Recall
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Distribution
Nationwide in the United States including Guam and the Northern Mariana Islands.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-21
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 81 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
McKesson Corporation dba McKesson Drug Company has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (McKesson Corporation dba McKesson Drug Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does McKesson Corporation dba McKesson Drug Company have FDA actions?
McKesson Corporation dba McKesson Drug Company has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0850-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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