Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported October 17, 2012
Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Actavis Mid Atlantic LLC recalled Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hy… - a low-severity action.
Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hy… was recalled by Actavis Mid Atlantic LLC in October 17, 2012. Reason: Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unkno…. Check the official notice for the remedy. Verify recall #D-005-2013 with the FDA Drug before acting.
The recall
Actavis Mid Atlantic LLC issued this low-severity FDA Drug recall-Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unkno….
- Low
- severity level
- Class III
- classification
- October 17, 2012
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-005-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-005-2013) was formally reported on October 17, 2012, with the manufacturer initiating the action on August 14, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Actavis Mid Atlantic LLC is listed as the recalling firm, operating out of Lincolnton, NC. Federal records list the affected scope as 14,868 Bottles.
The documented reason for this recall is: Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. Distribution data in the federal record shows the product reached: Nationwide & Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
14,868 Bottles
Related Recalls
6
5 from same agency
Product description
Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.
Reason for recall
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-005-2013 |
| Date reported | October 17, 2012 |
| Date initiated | August 14, 2012 |
| Recalling firm | Actavis Mid Atlantic LLC |
| Firm location | Lincolnton, NC |
| Affected scope | 14,868 Bottles |
| Distribution | Nationwide & Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-005-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.. Recalled by Actavis Mid Atlantic LLC. Units affected: 14,868 Bottles.
Why was this product recalled? ▼
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 17, 2012. Severity: Low. Recall number: D-005-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide & Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-005-2013) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 17, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.