Recall record at a glance
| Official record | D-1215-2015 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Apotex Inc. |
| Report date | Jul 15, 2015 |
| Recall initiation date | May 29, 2015 |
| Quantity | 4,584 bottles |
| Location | Toronto, N/A, Canada |
Official product description
Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India, NDC 60505-0209-1
Why the product was recalled
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Distribution information
Nationwide, Hawaii and Puerto Rico
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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