Boehringer Ingelheim Recalls SYNJARDY Tablets Due to Cross Contamination
Boehringer Ingelheim is recalling 998 bottles of SYNJARDY tablets due to cross-contamination with other products.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The hazard involves cross-contamination, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling 998 180-count bottles of SYNJARDY (empagliflozin and metformin hydrochloride) 5 mg/1000 mg tablets. The recall is being conducted because the product was found to be cross-contaminated with other products.
The affected product is identified by Lot # 603968 with an expiration date of 4/2019. The product is distributed nationwide. SYNJARDY is a prescription medication used for the treatment of type 2 diabetes.
Consumers and healthcare providers should check their inventory for this specific lot number. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using this medication.
The recalled product
- Product
- SYNJARDY (EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
- Brand
- SYNJARDY
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 603968 EXP 4/2019
Distribution
Distributed nationwide across the United States.
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