Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
Reported: April 17, 2019 Initiated: April 3, 2019 #D-1122-2019
Product Description
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
Reason for Recall
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 397 bottles
- Distribution
- AZ, CO
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30. Recalled by AVKARE Inc.. Units affected: 397 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 17, 2019. Severity: Low. Recall number: D-1122-2019.
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