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

Mckesson Medical-Surgical Inc. Corporate Office: Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) transdermal Systems Multipack, Rx only, MFG: Baxter Healthcare Corp, NDC 1

Is my product affected?

Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) transdermal Systems Multipack, Rx only, MFG: Baxter Healthcare Corp, NDC 10019-553-03

  • Brand TRANSDERM SCOP

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

What happened

McKesson Medical-Surgical Inc. is recalling Transderm Scop (scopolamine) transdermal patches, 1 mg/3 days, in multipacks of 10 patches, due to temperature abuse during storage that violated good manufacturing practice standards. The recall affects 56 cartons distributed nationwide across the United States. Because McKesson cannot identify which specific lot numbers were received by individual customers, recall notification letters were sent to customers with information about when the affected 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: 56 cartons/10 patches each 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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