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Sucrets Extra Strength Cherry DM (2014-10-22)
- Starting date:
- October 22, 2014
- Posting date:
- November 6, 2014
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-42111
Recalled Products
Sucrets Extra Strength Cherry DM
Reason
Recall is due to out of specification assay result obtained during routine stability of the product- the product failed assay result for Dextromethorphan HBR at 18 month time frame.
The acceptable range is 13.5-16.5 mg/Lozenges and they had a result of 17.76 mg/loz.
Depth of distribution
Retailers across Canada.
Affected products
Sucrets Extra Strength Cherry DM
DIN, NPN, DIN-HIM
DIN 02206196
Dosage form
Lozenge
Strength
15 mg/lozenge
Lot or serial number
021D2P21
Companies
- Recalling Firm
-
Associated National Brokerage Inc. (ANB)
199 Mathew Boyd Cres.
Newmarket
L3X 3C7
Ontario
CANADA
- Marketing Authorization Holder
-
Insight Pharmaceuticals LLC
200-900 Northbrook Drive
Trevose
19053
Pennsylvania
UNITED STATES