Recall record at a glance
| Official record | D-1347-2019 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Torrent Pharma Inc. |
| Report date | Jun 19, 2019 |
| Recall initiation date | May 21, 2019 |
| Quantity | 118,080 bottles |
| Location | Levittown, PA, United States |
Official product description
Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL. oz. (118 mL) bottle, NDC: 59741-119-06, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Assured.
Why the product was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Distribution information
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
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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