GENTAMICIN SULFATE Recall D-0687-2022
Description: Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
GENTAMICIN SULFATE Recall D-0687-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0687-2022 |
| Event ID | 89798 |
| Brand | GENTAMICIN SULFATE |
| Generic Name | GENTAMICIN SULFATE |
| Manufacturer | GENTAMICIN SULFATE |
| Original Package? | 1 |
| Active Substance | GENTAMICIN SULFATE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 43,956 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 |
| Product NDC | 52565-090 |
| 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 |
| Unique Ingredient Identifier | 8X7386QRLV |
| Drug Application Number | ANDA209233 |
| Structured Product Labeling (SPL ID) | bab39bb1-5c1b-498e-889a-18915032086b |
| Structured Product Labeling (SPL Set ID) | e2fd1885-afad-dcc8-ad64-27d45f63c00f |
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