The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1210-2019·Announced 2019-05-01

CMC Enterprise Pharmacy Recalls Clindamycin Bags Due to Sterility Concerns

CMC Enterprise Pharmacy is recalling 1,233 bags of Clindamycin 900 mg in NS 50 mL due to a lack of sterility assurance. The product was 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in injectable drugs) are categorized as Severe.

Plain-English summary

CMC Enterprise Pharmacy is recalling 1,233 bags of Clindamycin 900 mg in NS 50 mL. The recall was initiated due to a lack of sterility assurance. The affected lots are EA211905, EB061906, EB131907, EB221907, and EC251909, with expiration dates ranging from April 21, 2019, to June 23, 2019.

The recalled product was distributed in North Carolina. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected product and contact CMC Enterprise Pharmacy for further instructions or a replacement.

The recalled product

Product
Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Manufacturer
CMC Enterprise Pharmacy
Category
Drug — Antibiotic
Hazard
Affected units
1,233

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 (5)

  • Lots: EA211905 Exp. 4/21/2019
  • EB061906 Exp. 5/7/2019
  • EB131907 Exp. 5/14/2019
  • EB221907 Exp. 5/23/2019
  • EC251909 Exp. 6/23/2019

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.

See all 32 products in this recall →

Related recalls

Same manufacturer · CMC Enterprise Pharmacy

See all →

Same hazard · lack of sterility

See all →

Similar recalls