Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups Supply Disruption — Plastikon Healthcare LLC (Mode
Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups Supply Disruption — Plastikon Healthcare LLC (Mode is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups; Manufacturer: Plasti
| Drug name | Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups |
|---|---|
| Manufacturer | Plastikon Healthcare LLC |
| Recall/Disruption reason | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately c |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-1488-2022 |
| Initiation date | 20220607 |
| Quantity affected | 217,700 cups |
| Dosage form | Drugs |
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