ANAGRELIDE HYDROCHLORIDE Recall D-0992-2022
Description: Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
ANAGRELIDE HYDROCHLORIDE Recall D-0992-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0992-2022 |
| Event ID | 90182 |
| Brand | ANAGRELIDE HYDROCHLORIDE |
| Generic Name | ANAGRELIDE HYDROCHLORIDE |
| Manufacturer | ANAGRELIDE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | ANAGRELIDE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Distributed Nationwide in the USA |
| Quantity | 4224 cartons |
| Recall Reason | Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing. |
| Drug Classification | Class I |
| Drug Code Info | 20220608 |
| Product NDC | 0172-5240 0172-5241 |
| Drug UPC | 0301725240604 0301725241601 |
| Recall Initiation Date | 20220511 |
| Report Date | 20220608 |
| Classification Date | 20220608 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | YTM763Y5C8 |
| Drug Application Number | ANDA076468 |
| Structured Product Labeling (SPL ID) | fc800314-47d7-41ca-af8a-9222fbf5631c |
| Structured Product Labeling (SPL Set ID) | 6727d5d4-e8ec-4a85-bc82-ec70b641eecf |
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