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

Mckesson Medical-Surgical Inc. Corporate Office: Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton, Rx only, MFG: Avkare Inc., ND

Is my product affected?

Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton, Rx only, MFG: Avkare Inc., NDC 50268-523-15

  • Brand MECLIZINE HYDROCHLORIDE

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

What happened

McKesson Medical-Surgical Inc. is recalling Meclizine Hydrochloride Tablets, USP, 25 mg in 50-count cartons distributed nationwide. The recall was initiated due to current good manufacturing practice (cGMP) deviations involving temperature abuse during storage or handling. The affected product is a prescription medication manufactured by Avkare Inc. One box containing 50 blister packs has been identified in this recall.

The specific lot numbers cannot be identified by McKesson Medical-Surgical for individual customers, though the company provided distribution dates with recall letters to help customers determine whether they may have received impacted product based on the shipment timeframe. The record does not specify what actions affected consumers should take 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: 1 box/50 blister packs per box 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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