The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0156-2016·Announced 2015-11-04

Park Compounding Pharmacy Recalls Prostaglandin PGE-1 Due to Sterility Concerns

Park Compounding Pharmacy is recalling specific vials of Prostaglandin PGE-1 because the agency could not ensure the products remained sterile.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

Chen Shwezin, Inc. dba Park Compounding Pharmacy is recalling 2 vials of PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only. The recall is limited to Lot # 09082015@36 with an expiration date of 10/8/15. The product was distributed in California.

The recall was initiated due to a lack of assurance of sterility for all sterile compounded products within their expiry. The FDA has classified this recall as Class II.

Consumers who have this specific product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication.

The recalled product

Product
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
Manufacturer
Chen Shwezin, Inc. dba Park Compounding Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot#: 09082015@36
  • Exp 10/8/15

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 5 recalled by Chen Shwezin, Inc. dba Park Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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