Recall record at a glance
| Official record | D-307-2013 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Carib Import & Export, Inc. |
| Report date | May 8, 2013 |
| Recall initiation date | Feb 4, 2013 |
| Quantity | 480 bottles |
| Location | Miami, FL, United States |
Official product description
Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd., 97 East Street, Kingston, JAMAICA; UPC 0 83276 34324 8.
Why the product was recalled
CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
Distribution information
Nationwide, Bahamas, and Turks & Caicos Islands
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: not stated.
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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