Perry Drug Recalls HCG Injections Due to Sterility Assurance Concerns
Perry Drug Inc. is recalling HCG 10,000 U/10 mL PF Inj vials in Kansas and Missouri due to quality control issues affecting sterility assurance.
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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in a sterile injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
Perry Drug Inc. is recalling specific lots of HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx. The affected product is identified by NDC 88888-5012-34 and was distributed in Kansas and Missouri. The recall includes three vials per unit.
The recall was initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection. All lots of sterile products compounded by the pharmacy that are within expiry were recalled.
Consumers and healthcare providers should check their inventory for the specific lot codes 141015FF (11/15/14), 141024KK (11/24/14), and 141031CC (12/1/14). If these products are found, they should be returned to the pharmacy or contacting the recalling firm for instructions.
The recalled product
- Product
- HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
- Manufacturer
- Perry Drug Inc.
- Category
- Drug — Compounded Injectable
- Affected units
- 3
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 (6)
- 141015FF
- 11/15/14
- 141024KK
- 11/24/14
- 141031CC
- 12/1/14
Distribution
Part of a larger recall action
This product is one of 17 recalled by Perry Drug Inc. 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.
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