Atorvastatin Calcium Tablets Recalled for Manufacturing Process Deviations
Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets (10 mg) distributed nationwide due to manufacturing process deviations identified at Accord Healthcare. Affected lot numbers are A0523D, F14220, and J0622Q.
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: This is an FDA Class II recall involving manufacturing process deviations with no reported illnesses or injuries. No specific confirmed hazard is identified in the source, making this a precautionary quality-based recall.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Atorvastatin Calcium Tablets, USP, 10 mg (90-count bottles) distributed nationwide. The affected product is manufactured by Accord Healthcare, Inc. (Durham, NC) and is identified by lot numbers A0523D (expiration 5/31/2024), F14220 (expiration 7/31/2023), and J0622Q (expiration 1/31/2024), with NDC 68788-7630-9.
The recall was initiated due to manufacturing process deviations identified at the manufacturing facility following an FDA inspection.
This product is an Rx-only prescription medication distributed nationwide across the United States. A total of 158 bottles are affected by this recall.
Patients currently taking this medication should consult their healthcare provider or pharmacist regarding this recall.
The recalled product
- Product
- Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- cGMP-deviation
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 (6)
- Lot #: A0523D
- Exp 5/31/2024
- F14220
- Exp 7/31/2023
- J0622Q
- Exp 1/31/2024.
Distribution
Distributed nationwide across the United States.
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