Phenylephrine Syringes Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 1,310 syringes of Phenylephrine 0.8 mg/10 mL NS due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
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 sterility assurance, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
CMC Enterprise Pharmacy is recalling 1,310 syringes of Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL). The recall was initiated because the product lacks sterility assurance. The affected lots include ED041911, ED051910, ED081910, ED091909, ED101910, and ED111908, with expiration dates ranging from April 13, 2019, to April 20, 2019.
The recall is classified as Class II by the U.S. Food and Drug Administration. The affected product was distributed in North Carolina. No specific illnesses or injuries have been reported in the source text.
Consumers and healthcare providers should stop using the affected syringes and contact CMC Enterprise Pharmacy for further instructions or a refund.
The recalled product
- Product
- Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Manufacturer
- CMC Enterprise Pharmacy
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,310
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)
- Lots: ED041911 Exp. 4/13/2019
- ED051910 Exp. 4/14/2019
- ED081910 Exp. 4/17/2019
- ED091909 Exp. 4/18/2019
- ED101910 Exp. 4/19/2019
- ED111908 Exp. 4/20/2019
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 32 recalled by CMC Enterprise 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.
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