The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-660-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Pap 300 mg-phent 10 mg-prost 100 mcg

Clinical Specialties Compounding Pharmacy is recalling specific lots of Pap 300 mg-phent 10 mg-prost 100 mcg due to FDA inspection findings regarding quality control and lack of assurance of sterility.

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, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in a compounded pharmaceutical product.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling specific lots of Pap 300 mg-phent 10 mg-prost 100 mcg. The recall is being conducted because FDA inspection findings resulted in concerns regarding quality control processes and a lack of assurance of sterility.

The affected product is a 96ml total quantity. The specific lots subject to recall are: Lot number CABDBFAC:52 (Exp date: 5/16/2013), Lot number CABDBBAB:40 (Exp date: 4/11/2013), Lot number CABDCAAC:15 (Exp date: 5/21/2013), Lot number CABDCCAC:75 (Exp date: 5/23/2013), and Lot number CABDAFAD:77 (Exp date: 6/3/2013).

The product was distributed in Florida, Georgia, and South Carolina. Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled lots, they should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Manufacturer
Clinical Specialties Compounding Pharmacy
Category
Drug — Compounded Pharmaceutical
Hazard
Affected units
96

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 (9)

  • Lot number CABDBFAC:52
  • Exp date: 5/16/2013
  • Lot number CABDBBAB:40
  • Exp date: 4/11/2013
  • Lot number CABDCAAC:15
  • Exp date: 5/21/2013
  • Lot number CABDCCAC:75
  • Exp date: 5/23/2013 and Lot number CABDAFAD:77
  • Exp date: 6/3/2013.

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 49 recalled by Clinical Specialties 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 49 products in this recall →

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