Drug recall
CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd…
FDA recall event 72402 · Class II · Chen Shwezin, Inc. dba Park Compounding Pharmacy
Key facts
| Event ID | 72402 |
|---|---|
| Recall numbers | D-0156-2016, D-0157-2016, D-0158-2016, D-0159-2016, D-0160-2016 |
| Recalling firm | Chen Shwezin, Inc. dba Park Compounding Pharmacy |
| Product type | Drugs |
| Products | CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258, METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258, PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258, TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258, TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: all sterile compounded products within expiry |
| Initiation date | Oct 6, 2015 |
| Report date | Nov 4, 2015 |
| Termination date | Nov 27, 2015 |
| City | Westlake Village |
| State | CA |
| Country | United States |
| FEI number | 3005256616 |
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: