The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0511-2023·Announced 2023-04-12

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units
158

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.

Part of a larger recall action

This product is one of 17 recalled by Preferred Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

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