Why it was recalled
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Product description
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
Lot numbers, UPCs & expiration codes
Item # 370339, all lots
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1122-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 2, 2017
- FDA report date
- Aug 30, 2017
- Quantity
- 4,715 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-1122-2017, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 77869
- Address
- 17177 N Laurel Park Dr Ste 233
- Code information
- Item # 370339, all lots
- Postal code
- 48152-3951
- Report date
- Aug 30, 2017
- Product type
- Drugs
- Recall number
- D-1122-2017
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 4,715 bottles
- Termination date
- Jul 16, 2024
- Reason for recall
- Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 2, 2017
- Initial firm notification
- Press Release
- Center classification date
- Aug 24, 2017