The Recall Desk
SevereFDA (Drugs)·D-0159-2016·Announced 2015-11-04

Park Compounding Pharmacy Recalls Caffeine and Sodium Benzoate Vials

Park Compounding Pharmacy is recalling specific vials of Caffeine + Sodium Benzoate 500mg/mL due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe severity score per the rubric for drug recalls with potential for temporary or medically reversible health consequences.

Plain-English summary

Chen Shwezin, Inc. dba Park Compounding Pharmacy is recalling 2 vials of Caffeine + Sodium Benzoate 500mg/mL, 35 mL vial, Rx only. The recall is due to a lack of assurance of sterility for all sterile compounded products within the expiry date.

The affected product is identified by Lot# 08062015@27 and has an expiration date of 11/4/15. The product was distributed in California (CA).

Consumers who have this specific product should contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
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
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 (3)

  • Lot# 08062015@27
  • Exp
  • 11/4/15

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 →

Related recalls

Same manufacturer · Chen Shwezin, Inc. dba Park Compounding Pharmacy

See all →

Same hazard · sterility failure

See all →