Qualitest Recalls Amlodipine Besylate Tablets Due to Oversized Size
Qualitest Pharmaceuticals is recalling 2,808 bottles of Amlodipine Besylate tablets because one lot contains oversized tablets.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Qualitest Pharmaceuticals is voluntarily recalling 2,808 bottles of Amlodipine Besylate Tablets USP, 10 mg, 1000 count bottles (NDC 0603-2110-32). The recall affects Lot T018H14A, which has an expiration date of 08/16. The product was distributed nationwide.
The recall was initiated because one lot was found to contain oversized tablets, which failed to meet tablet specifications. This is a Class II recall, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
- Manufacturer
- Qualitest Pharmaceuticals
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,808
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot T018H14A
- Exp 08/16
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Qualitest Pharmaceuticals
See all →- LowQualitest Recalls Allopurinol Tablets Due to Oversized and Discolored Appearance
FDA (Drugs) · 2015-09-09
- LowQualitest Recalls HydrOXYzine Tablets Due to Unreadable Identification Codes
FDA (Drugs) · 2015-07-22
- ModerateQualitest Recalls Disulfiram Tablets Due to Dissolution Failure
FDA (Drugs) · 2015-07-08
- LowQualitest Recalls Promethazine VC With Codeine Syrup Due to Impurity
FDA (Drugs) · 2015-04-15
- ModerateQualitest Recalls Promethazine DM Syrup Due to Plastic Particulates
FDA (Drugs) · 2015-03-18
Same hazard · physical defect
See all →- HighThermodilution Catheter May Bend During Use, Causing Monitor Errors
FDA (Devices) · 2023-04-19
- ModerateBard Clean-Cath Intermittent Catheter Recalled for Packaging and Tip Defects
FDA (Devices) · 2021-04-28
- HighFerring Recalls ZOMA-Jet 5 Demonstration Kits Due to Defective Delivery System
FDA (Drugs) · 2021-04-07
- HighROi CPS Recalls Custom Procedure Packs with Flaking Gauze Sponges
FDA (Devices) · 2021-01-06
- HighGE Healthcare Recalls Flow Sensor Service Parts with Damaged Tubes
FDA (Devices) · 2020-11-11