Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL unit dose cups (NDC 0121-0978-10), b) 100-count box (NDC 0121-0978-00), Rx only, MFG: Pharmaceutical Associates Inc.
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical is recalling Diphenhydramine HCl oral solution, USP, 25 mg/10 mL, supplied in 10 mL unit dose cups or 100-count boxes. The recall was issued due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse of the product. One case containing 100 unit dose cups was affected and distributed nationwide throughout the United States.
McKesson is unable to identify the specific lot numbers received by individual customers, but has provided distribution and shipping dates in letters sent to affected parties. The source document does not specify a remedy or action for affected consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP deviations: Temperature abuse
Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 1 case/100 unit dose cups 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.