Drug recall
Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide 2gm/4gm/4gm/30ml Banana/Marshmallow Oral Oil Suspension…
FDA recall event 91469 · Class II · Wedgewood Village Pharmacy, LLC
Key facts
| Event ID | 91469 |
|---|---|
| Recall numbers | V-0042-2023, V-0043-2023, V-0044-2023, V-0045-2023 |
| Recalling firm | Wedgewood Village Pharmacy, LLC |
| Product type | Veterinary |
| Products | Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide 2gm/4gm/4gm/30ml Banana/Marshmallow Oral Oil Suspension. Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085. Packaged in…, Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide 2gm/4gm/4gm/30ml Susp 900 ml Apple/Molasses. Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085. Packaged in amber round…, Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide 2gm/4gm/4gm/30ml Susp 900 ml Apple. Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085. Packaged in amber round plastic…, Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide 2gm/4gm/4gm/30ml Susp 900 ml Peppermint. Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085. Packaged in amber round plastic… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Subpotent drug: Omeprazole concentration being lower than the labeled amount of 2 gm/30 mL |
| Initiation date | Dec 15, 2022 |
| Report date | Feb 1, 2023 |
| City | Swedesboro |
| State | NJ |
| Country | United States |
| FEI number | 3001779702 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: