Perry Drug Recalls Phenylephrine Syringes Due to Sterility Concerns
Perry Drug Inc. is recalling specific lots of compounded Phenylephrine HCl syringes due to quality control issues affecting sterility assurance.
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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in a sterile product, which poses a significant risk of infection or serious injury.
Plain-English summary
Perry Drug Inc. is recalling 8 prefilled syringes of Phenylephrine HCl (100 mcg/mL) in 0.9% NaCl (1 mg / 10 mL). The affected product is a compounded prescription medication manufactured by Perry Drug Compounding Pharmacy in Overland Park, Kansas. The recall covers specific lots with codes 141008AA, 141017E, and 141030EE.
The recall was initiated due to a lack of sterility assurance. During a recent FDA inspection, concerns were identified regarding quality control procedures that present a potential risk to the sterility of the products. All lots of sterile products compounded by the pharmacy that are within their expiration date were recalled.
The affected products were distributed in Kansas and Missouri. Consumers and healthcare providers should check their inventory for the specific lot codes listed above and stop using the product if it matches the recalled description.
The recalled product
- Product
- Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12
- Manufacturer
- Perry Drug Inc.
- Affected units
- 8
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)
- 141008AA
- 11/8/14
- 141017E
- 11/17/14
- 141030EE
- 11/30/14
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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