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FDA (Drug enforcement)Recalled 2022-04-13closedclass ii

Mckesson Medical-Surgical Inc. Corporate Office: Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: Sun Pharmaceuticals, NDC 63304-616-50

Is my product affected?

Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: Sun Pharmaceuticals, NDC 63304-616-50

  • Brand DOXYCYCLINE

Check against the official notice below — it lists the full affected range.

What happened

Sun Pharmaceuticals distributed Doxycycline Capsules, USP, 100 mg through McKesson Medical-Surgical Inc. A recall was issued for 3 bottles due to temperature abuse during storage that violated manufacturing standards (cGMP deviations). The affected product was distributed nationwide throughout the United States. Because McKesson Medical-Surgical cannot identify which specific lot number was received by individual customers, the company is providing each customer with the distribution date and the date range during which impacted product may have been shipped to them.

The source document does not specify a remedy or what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

cGMP deviations: Temperature abuse

Details from the source

Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 3 bottles Lot/code info: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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