Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Reported: July 19, 2023 Initiated: July 5, 2023 #D-0913-2023
Product Description
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Reason for Recall
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Details
- Recalling Firm
- Teva Pharmaceuticals USA Inc
- Units Affected
- 180 bottles
- Distribution
- Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 180 bottles.
Why was this product recalled? ▼
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2023. Severity: Moderate. Recall number: D-0913-2023.
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