Qualitest Pharmaceuticals Recall: PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains:
Qualitest Pharmaceuticals Recall: PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Qualitest Pharmaceuticals; Product: PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25
| Recalling firm | Qualitest Pharmaceuticals |
|---|---|
| Product | PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811. |
| Reason for recall | Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point. |
| Classification | Class III (least serious — unlikely to cause adverse health consequences) |
| Status | Terminated |
| Distribution | Nationwide |
| Recall initiated | 20150325 |
| Recall number | D00432-2015 |
| Category | drug |
| State | AL |
| Country | United States |
$29/mo
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