PREDNISONE Recall D-1330-2022
Description: Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.
PREDNISONE Recall D-1330-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1330-2022 |
| Event ID | 90634 |
| Brand | PREDNISONE |
| Generic Name | PREDNISONE |
| Manufacturer | PREDNISONE |
| Original Package? | 1 |
| Active Substance | PREDNISONE |
| Drug Route | ORAL |
| Distribution | US Nationwide |
| Quantity | 1032 bottles |
| Recall Reason | Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets |
| Drug Classification | Class II |
| Drug Code Info | 20220817 |
| Product NDC | 64380-784 64380-785 64380-949 |
| Product NUI | N0000175576 N0000175450 |
| Drug UPC | 0364380785088 0364380784067 0364380785064 |
| Pharma Class (EPC) | Corticosteroid [EPC] |
| Recall Initiation Date | 20220719 |
| Report Date | 20220817 |
| Classification Date | 20220809 |
| Address | 2 Tower Center Blvd Ste 1102 East Brunswick, NJ 08816-1100 United States |
| Recalling Firm | Strides Pharma Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | VB0R961HZT |
| Drug Application Number | ANDA208412 |
| Structured Product Labeling (SPL ID) | b0517ba5-d086-4c92-ae91-cd9c4c2f9faf |
| Structured Product Labeling (SPL Set ID) | 2ef05381-faad-4e0f-b58d-9f2236a04a2c |
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