The Recall Desk
ModerateFDA (Drugs)·D-0300-2021·Announced 2021-03-24

Direct Rx Recalls Nortriptyline HCL Capsules Due to cGMP Deviation

Direct Rx is recalling 17 bottles of Nortriptyline HCL 10 mg capsules because the active ingredient was taken from an unqualified supplier lot.

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, and the source text describes a cGMP deviation regarding unqualified ingredients without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Direct Rx is recalling 17 bottles of Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles. The product is prescription-only and was distributed in Georgia. The specific lot number is 28DE2002 with an expiration date of 10/31/22.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. The quantity of active ingredient used for this product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
Manufacturer
Direct Rx
Category
Drug — Prescription Medication
Hazard
Affected units
17

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 (1)

  • Lot#: 28DE2002 Exp 10/31/22

Distribution

Distributed in 1 state:

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