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
Reported: May 11, 2022 Initiated: April 21, 2022 #D-0850-2022
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
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.
Details
- Recalling Firm
- McKesson Corporation dba McKesson Drug Company
- Units Affected
- 55,440 tubes
- Distribution
- Nationwide in the United States including Guam and the Northern Mariana Islands.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by McKesson Corporation dba McKesson Drug Company. Units affected: 55,440 tubes.
Why was this product recalled? ▼
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 11, 2022. Severity: Moderate. Recall number: D-0850-2022.
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