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.
Reported: June 15, 2022 Initiated: April 13, 2022 #D-1101-2022
Product Description
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.
Reason for Recall
cGMP deviations: Temperature abuse
Details
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Units Affected
- 1 case/100 unit dose cups
- Distribution
- USA nationwide.
- Location
- Richmond, VA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 1 case/100 unit dose cups.
Why was this product recalled? ▼
cGMP deviations: Temperature abuse
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1101-2022.
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