Recall D-0686-2022
Description: Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Recall D-0686-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0686-2022 |
Event ID | 89798 |
Distribution | Nationwide in the USA and Puerto Rico |
Quantity | 355,672 tubes |
Recall Reason | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
Drug Classification | Class II |
Drug Code Info | 20220330 |
Recall Initiation Date | 20220315 |
Report Date | 20220330 |
Classification Date | 20220321 |
Address | 105 Lincoln Avenue Buena, NJ 08310 United States |
Recalling Firm | Teligent Pharma, Inc. |
Initial Notification | Letter |
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