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

Mckesson Medical-Surgical Inc. Corporate Office: Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03

Is my product affected?

Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03

  • Brand NALTREXONE HYDROCHLORIDE

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

What happened

McKesson Medical-Surgical Inc. is recalling Naltrexone Hydrochloride Tablets, USP, 50 mg in 100-count bottles manufactured by Mallinckrodt Inc. The recall affects approximately 4 bottles containing 30 tablets per bottle that were distributed nationwide across the United States. The products are being recalled due to Current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during storage or handling.

Because McKesson Medical-Surgical is unable to identify the specific lot numbers received by individual customers, affected consignees received individual letters containing the distribution date and the dates when impacted product may have been shipped to them. The recall notice does not specify a remedy or what action affected consumers should take.

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: 4 bottles/30 tablets per bottle 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.

Related recalls

All FDA (Drug enforcement) recalls

Hurt by this product? Start a free Case Check

ProductRisk is not a law firm and does not provide legal services or legal advice. ProductRisk is a free consumer product-safety information service operated by Plaintify, Inc., a technology company. If you ask to be connected with a law firm, any legal services are provided by that firm — not by ProductRisk or Plaintify.

Privacy · Plaintify