Recalls / Class II
Class IID-1122-2017
Product
Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47
- Affected lot / code info
- Item # 370339, all lots
Why it was recalled
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, Livonia, Michigan 48152-3951
Distribution
- Quantity
- 4,715 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-08-02
- FDA classified
- 2017-08-24
- Posted by FDA
- 2017-08-30
- Terminated
- 2024-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1122-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.