Agency classClass IIOur severity:High FDA (Drugs)·D-0406-2023·Announced 2023-03-08

FDA Recalls Rosuvastatin Tablets Due to Manufacturing Practice Deviations

Accord Healthcare is recalling Rosuvastatin 20 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations. The deviations could affect product quality and safety.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA classified this as Class II, indicating potential for serious adverse health consequences from manufacturing practice deviations. No illnesses or injuries are mentioned in the source, limiting the score to 3 per the rubric.

Plain-English summary

Accord Healthcare is recalling Rosuvastatin 20 mg tablets (NDC 16729-286-15 and 16729-286-17) distributed throughout the United States, Puerto Rico, and Canada. The recall affects 43,302 bottles and was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations.

CGMP deviations relate to how medications are manufactured and can affect product quality and safety. Patients currently taking Rosuvastatin should consult their healthcare provider for guidance on whether to discontinue the medication.

Consumers with unused bottles should return them to their pharmacy or follow medication disposal instructions provided by their pharmacist. Healthcare providers may contact Accord Healthcare, Inc. for information about replacement product availability.

The recalled product

Product: ROSUVASTATIN (ROSUVASTATIN)
Brand: ROSUVASTATIN
Manufacturer: Accord Healthcare, Inc.
Category: Drug
Hazard: cgmp-deviation
Affected units: 43,302

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 (20)

Batches: a) P2006560
Exp. Date 11/30/2023
P2101562
Exp. Date 2/28/2024
b) P2006561
P2006562
P2006587
P2100035
P2006600
P2006603
P2006604
P2006605
P2006606
P2100542
Exp. Date 12/31/2023
P2100543
P2100544
P2100545
P2101485
P2101484

UPCs (2)

316729286152
316729286176

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, 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 67 products in this recall →

Same brand · ROSUVASTATIN

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Accord Healthcare recalls Rosuvastatin tablets for manufacturing deviations
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Same hazard · cgmp deviation