Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC Supply Disruption — American Pharmaceutical Ingred
Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC Supply Disruption — American Pharmaceutical Ingred is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC; Manufacturer: Americ
| Drug name | Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC |
|---|---|
| Manufacturer | American Pharmaceutical Ingredients LLC |
| Recall/Disruption reason | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-0476-2018 |
| Initiation date | 20180209 |
| Quantity affected | 55500 g |
| Dosage form | Drugs |
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